Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    cd19 rosenberg
Previous Study | Return to List | Next Study

CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00924326
Recruitment Status : Active, not recruiting
First Posted : June 18, 2009
Results First Posted : March 21, 2019
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Steven Rosenberg, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Mediastinal B-cell Lymphoma
Diffuse, Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma Transformed From Follicular Lymphoma
Mantle Cell
Interventions Drug: Fludarabine
Drug: Cyclophosphamide
Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL
Drug: Aldesleukin
Enrollment 43
Recruitment Details  
Pre-assignment Details Three patients treated in arm 1 (1x10e9-1x10e10 cells/kg + high dose IL2) had disease progression and were then retreated in Period 2 (1x10e9-1x10e10 cells/kg + high dose IL2).
Arm/Group Title 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture)
Hide Arm/Group Description

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Period Title: Dose Administration
Started 8 2 5 6 7 10 1 2 2
Completed 8 2 5 6 7 10 1 2 2
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: 1x10^9-1x10^10 + High Dose Retreat
Started 3 0 0 0 0 0 0 0 0
Completed 3 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture) Total
Hide Arm/Group Description

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Total of all reporting groups
Overall Number of Baseline Participants 8 2 5 6 7 10 1 2 2 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 5 participants 6 participants 7 participants 10 participants 1 participants 2 participants 2 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
2
 100.0%
5
 100.0%
5
  83.3%
5
  71.4%
8
  80.0%
1
 100.0%
2
 100.0%
1
  50.0%
37
  86.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
2
  28.6%
2
  20.0%
0
   0.0%
0
   0.0%
1
  50.0%
6
  14.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 2 participants 5 participants 6 participants 7 participants 10 participants 1 participants 2 participants 2 participants 43 participants
55.5  (5.7) 52.0  (12.7) 40.4  (6.8) 58.0  (8.6) 55.0  (13.7) 52.1  (15.2) 40.0 51.5  (2.1) 58.5  (10.6) 52.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 5 participants 6 participants 7 participants 10 participants 1 participants 2 participants 2 participants 43 participants
Female
0
   0.0%
1
  50.0%
2
  40.0%
4
  66.7%
0
   0.0%
2
  20.0%
0
   0.0%
0
   0.0%
1
  50.0%
10
  23.3%
Male
8
 100.0%
1
  50.0%
3
  60.0%
2
  33.3%
7
 100.0%
8
  80.0%
1
 100.0%
2
 100.0%
1
  50.0%
33
  76.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 5 participants 6 participants 7 participants 10 participants 1 participants 2 participants 2 participants 43 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.7%
Not Hispanic or Latino
8
 100.0%
2
 100.0%
4
  80.0%
6
 100.0%
7
 100.0%
9
  90.0%
1
 100.0%
2
 100.0%
2
 100.0%
41
  95.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 5 participants 6 participants 7 participants 10 participants 1 participants 2 participants 2 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
White
8
 100.0%
2
 100.0%
4
  80.0%
5
  83.3%
6
  85.7%
10
 100.0%
1
 100.0%
2
 100.0%
2
 100.0%
40
  93.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 2 participants 5 participants 6 participants 7 participants 10 participants 1 participants 2 participants 2 participants 43 participants
8
 100.0%
2
 100.0%
5
 100.0%
6
 100.0%
7
 100.0%
10
 100.0%
1
 100.0%
2
 100.0%
2
 100.0%
43
 100.0%
1.Primary Outcome
Title Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
Hide Description Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat Arm/Group: "3 participants in group 1 (1x10e9-1x10e10 cells/kg + high-dose IL2)) initially responded but were then retreated in group 2 after progression."
Arm/Group Title 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture)
Hide Arm/Group Description:

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Overall Number of Participants Analyzed 8 3 2 5 6 7 10 1 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Remission
2
  25.0%
3
 100.0%
2
 100.0%
3
  60.0%
3
  50.0%
2
  28.6%
6
  60.0%
0
   0.0%
2
 100.0%
2
 100.0%
Partial Remission
4
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
3
  42.9%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Stable Disease
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Progressive Disease
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
2
  28.6%
2
  20.0%
1
 100.0%
0
   0.0%
0
   0.0%
Not Evaluable
1
  12.5%
0
   0.0%
0
   0.0%
1
  20.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 101 months and 17 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture)
Hide Arm/Group Description:

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Overall Number of Participants Analyzed 8 3 2 5 6 7 10 1 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
1
  33.3%
2
 100.0%
5
 100.0%
6
 100.0%
7
 100.0%
10
 100.0%
1
 100.0%
2
 100.0%
2
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 101 months and 17 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture)
Hide Arm/Group Description

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

Cyclophosphamide (Days -5 to -3): 300mg/m^2 intravenous (IV) over 60 minutes

Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m^2 intravenous (IV) over 30 minutes

Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.

All-Cause Mortality
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)      0/3 (0.00%)      0/2 (0.00%)      1/5 (20.00%)      0/6 (0.00%)      0/7 (0.00%)      0/10 (0.00%)      0/1 (0.00%)      0/2 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/8 (87.50%)      1/3 (33.33%)      2/2 (100.00%)      3/5 (60.00%)      2/6 (33.33%)      2/7 (28.57%)      7/10 (70.00%)      1/1 (100.00%)      2/2 (100.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders                     
Neutrophils/granulocytes (ANC/AGC)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Lymphopenia  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Cardiac disorders                     
Supraventricular and nodal arrhythmia::Atrial fibrillation  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Valvular heart disease  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Hypotension  1  0/8 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 2/10 (20.00%)  2 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Supraventricular and nodal arrhythmia::Supraventricular tachycardia  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Supraventricular and nodal arrhythmia::Sinus tachycardia  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Left ventricular systolic dysfunction  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Gastrointestinal disorders                     
Colitis  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Dysphagia (difficulty swallowing)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
General disorders                     
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 2/2 (100.00%)  2 0/2 (0.00%)  0
Death not associated with CTCAE term  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Syndromes - Other (Myelodysplastic syndrome)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations                     
Febrile neutropenia  1 [1]  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 4/10 (40.00%)  4 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Infection (documented clinically or microbiologically)  1 [2]  1/8 (12.50%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Opportunistic infection associated with >=Grade 2 Lymphopenia  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection  1 [3]  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection  1 [4]  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Metabolism and nutrition disorders                     
Creatinine  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders                     
CNS cerebrovascular ischemia  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Encephalopathy  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Seizure  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Somnolence/depressed level of consciousness  1  2/8 (25.00%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 4/10 (40.00%)  4 0/1 (0.00%)  0 0/2 (0.00%)  0 2/2 (100.00%)  2
Confusion  1  0/8 (0.00%)  0 0/3 (0.00%)  0 2/2 (100.00%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 3/10 (30.00%)  3 1/1 (100.00%)  1 2/2 (100.00%)  2 2/2 (100.00%)  2
Neuropathy: cranial::CN VII Motor-face; Sensory-taste  1  0/8 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Pyramidal tract dysfunction  1 [5]  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Speech impairment (e.g., dysphasia or aphasia)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0 6/10 (60.00%)  6 0/1 (0.00%)  0 2/2 (100.00%)  3 2/2 (100.00%)  2
Myelitis  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Ataxia (incoordination)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Cognitive disturbance  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Mood alteration::Agitation  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Neuropathy: motor  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/10 (20.00%)  2 0/1 (0.00%)  0 1/2 (50.00%)  2 1/2 (50.00%)  1
Tremor  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Psychosis (hallucinations/delusions)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Renal and urinary disorders                     
Renal failure  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Incontinence, urinary  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Hypoxia  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0 1/2 (50.00%)  1
Dyspnea (shortness of breath)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0 1/2 (50.00%)  1
Vascular disorders                     
Thrombosis/thrombus/embolism  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
[2]
with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Abdomen NOS
[3]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood
[4]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Urinary tract NOS
[5]
(e.g., increased tone, hyperreflexia, positive Babinski, decreased fine motor coordination)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat 0.5x10^7 Cells/kg 2.5x10^6 Cells/kg 1.0x10^6 Cells/kg 1.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Reduced Chemo) 6.0x10^6 Cells/kg (Reduced Chemo) 2.0x10^6 Cells/kg (Moderate Chemo) 2.0x10^6 Cells/kg (9-12 Days Culture)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      3/3 (100.00%)      2/2 (100.00%)      5/5 (100.00%)      6/6 (100.00%)      7/7 (100.00%)      10/10 (100.00%)      1/1 (100.00%)      2/2 (100.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders                     
Blood/Bone Marrow - Other (Hypogammaglobulinemia (IG A))  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Blood/Bone Marrow - Other (Hypogammaglobulinemia (IGG))  1  1/8 (12.50%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Blood/Bone Marrow - Other (Hypogammaglobulinemia (IG M))  1  1/8 (12.50%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Hemoglobin  1  6/8 (75.00%)  6 2/3 (66.67%)  2 1/2 (50.00%)  1 4/5 (80.00%)  4 3/6 (50.00%)  3 3/7 (42.86%)  3 8/10 (80.00%)  8 1/1 (100.00%)  1 1/2 (50.00%)  1 2/2 (100.00%)  2
Leukocytes (total WBC)  1  8/8 (100.00%)  9 3/3 (100.00%)  3 2/2 (100.00%)  3 5/5 (100.00%)  5 6/6 (100.00%)  6 5/7 (71.43%)  5 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Lymphopenia  1  8/8 (100.00%)  8 3/3 (100.00%)  5 2/2 (100.00%)  2 5/5 (100.00%)  5 6/6 (100.00%)  6 7/7 (100.00%)  7 10/10 (100.00%)  10 1/1 (100.00%)  1 1/2 (50.00%)  1 2/2 (100.00%)  2
Neutrophils/granulocytes (ANC/AGC)  1  8/8 (100.00%)  9 3/3 (100.00%)  3 2/2 (100.00%)  3 5/5 (100.00%)  5 5/6 (83.33%)  5 7/7 (100.00%)  7 9/10 (90.00%)  9 0/1 (0.00%)  0 1/2 (50.00%)  1 2/2 (100.00%)  2
PTT (Partial Thromboplastin Time)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Platelets  1  8/8 (100.00%)  8 3/3 (100.00%)  3 2/2 (100.00%)  2 5/5 (100.00%)  5 4/6 (66.67%)  4 1/7 (14.29%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 1/2 (50.00%)  1
Cardiac disorders                     
Left ventricular systolic dysfunction  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Pulmonary hypertension  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Supraventricular and nodal arrhythmia::Sinus tachycardia  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Congenital, familial and genetic disorders                     
Hypotension  1  5/8 (62.50%)  5 2/3 (66.67%)  2 0/2 (0.00%)  0 0/5 (0.00%)  0 2/6 (33.33%)  2 1/7 (14.29%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Ear and labyrinth disorders                     
Hearing: patients without baseline audiogram and not enrolled in a monitoring program  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Eye disorders                     
Hemorrhage/Bleeding - Other (Subconjunctival hemorrhages)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Gastrointestinal disorders                     
Anorexia  1  1/8 (12.50%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Diarrhea  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Nausea  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Pain::Abdomen NOS  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
General disorders                     
Fatigue (asthenia, lethargy, malaise)  1  4/8 (50.00%)  4 2/3 (66.67%)  4 0/2 (0.00%)  0 1/5 (20.00%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/8 (12.50%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 3/7 (42.86%)  3 6/10 (60.00%)  6 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Weight loss  1  1/8 (12.50%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations                     
Febrile neutropenia  1 [1]  3/8 (37.50%)  3 2/3 (66.67%)  2 2/2 (100.00%)  2 5/5 (100.00%)  5 4/6 (66.67%)  4 4/7 (57.14%)  4 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Infection (documented clinically or microbiologically)  1 [2]  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 2/5 (40.00%)  2 2/6 (33.33%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 2/5 (40.00%)  2 2/6 (33.33%)  2 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection  1 [3]  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Nerve-peripheral  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 3/6 (50.00%)  3 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with normal ANC or Grade 3 or 4 neutrophils::Blood  1  4/8 (50.00%)  4 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection  1 [4]  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection  1 [5]  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Infection with unknown ANC::Urinary tract NOS  1  0/8 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders                     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  2/8 (25.00%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Albumin, serum-low (hypoalbuminemia)  1  2/8 (25.00%)  2 0/3 (0.00%)  0 0/2 (0.00%)  0 2/5 (40.00%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  2/8 (25.00%)  2 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Calcium, serum-low (hypocalcemia)  1  5/8 (62.50%)  5 2/3 (66.67%)  2 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Creatinine  1  1/8 (12.50%)  1 1/3 (33.33%)  2 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Magnesium, serum-high (hypermagnesemia)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  2/8 (25.00%)  3 1/3 (33.33%)  2 1/2 (50.00%)  1 3/5 (60.00%)  3 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 2/7 (28.57%)  2 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Uric acid, serum-high (hyperuricemia)  1  2/8 (25.00%)  2 2/3 (66.67%)  2 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders                     
Cognitive disturbance  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Confusion  1  0/8 (0.00%)  0 2/3 (66.67%)  2 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Dizziness  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Encephalopathy  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Laryngeal nerve dysfunction  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Mood alteration::Agitation  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Mood alteration::Anxiety  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 2/5 (40.00%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Mood alteration::Depression  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Neuropathy: cranial: CN III Pupil, upper eyelid, extra ocular movements  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Neuropathy: motor  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 3/10 (30.00%)  3 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Neuropathy: sensory  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/10 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Pain::Head/headache  1  1/8 (12.50%)  1 2/3 (66.67%)  2 2/2 (100.00%)  2 1/5 (20.00%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Psychosis (hallucinations/delusions)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/10 (20.00%)  2 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Speech impairment (e.g., dysphasia or aphasia)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 3/10 (30.00%)  3 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Syncope (fainting)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/10 (10.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Tremor  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 6/10 (60.00%)  6 1/1 (100.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders                     
Renal failure  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Renal/Genitourinary - Other (low urine output)  1  0/8 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Renal/Genitourinary - Other (Oliguria)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Dyspnea (shortness of breath)  1  1/8 (12.50%)  1 1/3 (33.33%)  1 0/2 (0.00%)  0 2/5 (40.00%)  2 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory::Nose  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory::Nose  1  0/8 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Hypoxia  1  0/8 (0.00%)  0 2/3 (66.67%)  2 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Pleural effusion (non-malignant)  1  1/8 (12.50%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Pneumonitis/pulmonary infiltrates  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Vascular disorders                     
Acute vascular leak syndrome  1  4/8 (50.00%)  4 1/3 (33.33%)  1 0/2 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
Thrombosis/thrombus/embolism  1  0/8 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/2 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
(fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C)
[2]
with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Blood
[3]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Colon
[4]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Urinary tract NOS
[5]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Wound
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Rosenberg, M.D., Ph.D.
Organization: National Cancer Institute
Phone: 240-858.3080
EMail: sar@nih.gov
Publications of Results:
James N. Kochenderfer, M.D., Mark E. Dudley, Ph.D., Sadik H. Kassim, Ph.D., Robert O. Carpenter, James C. Yang, MD, Giao Q. Phan, MD, Marybeth S. Hughes, MD, Richard M. Sherry, MD, Steven Feldman, Ph.D., David Spaner, MD, PhD, Debbie-Ann N. Nathan, RN, Kathleen E. Morton, RN, Mary Ann Toomey, RN, and Steven A. Rosenberg, M.D., Ph.D. Effective Treatment of Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma with Autologous T Cells Genetically-Engineered to Express an Anti-CD19 Chimeric Antigen Receptor. Oral Abstract Presentation 12-8-13 in New Orleans, LA at the American Society of Hematology annual meeting. Blood Annual Meeting abstract 2013. 122:168.
James N. Kochenderfer, Mark E. Dudley, Robert O. Carpenter, Sadik H. Kassim, Jeremy J. Rose, William G. Telford, Frances T. Hakim, David C. Halverson, Daniel H. Fowler, Nancy M. Hardy, Anthony R. Mato, Dennis D. Hickstein, Juan C. Gea-Banacloche, Steven Z. Pavletic, Claude Sportes, Irina Maric, Steven A. Feldman, Brenna G. Hansen, Jennifer S. Wilder, Bazetta Blacklock-Schuver, Bipulendu Jena, Michael R. Bishop, Steven A. Rosenberg*, Ronald E. Gress* (co-senior authors). Donor-derived anti-CD19 chimeric-antigen-receptor-expressing T cells cause regression of malignancy persisting after allogeneic hematopoietic stem cell transplantation. Oral Abstract Presentation 12-8-13 in New Orleans, LA at the American Society of Hematology annual meeting. Blood Annual Meeting abstracts 2013. 122:151.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Steven Rosenberg, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00924326    
Obsolete Identifiers: NCT00862069
Other Study ID Numbers: 090082
09-C-0082
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: January 4, 2019
Results First Posted: March 21, 2019
Last Update Posted: April 20, 2020