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Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma (273)

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: NCT01685606
Recruitment Status : Terminated (Lack of accrual and low efficacy)
First Posted : September 14, 2012
Results First Posted : June 26, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Peter Quesenberry, Brown University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mantle Cell Lymphoma
Diffuse Large Cell Lymphoma
Burkitts Lymphoma
T Cell Lymphomas
Acute Myeloid Leukemia/Acute Lymphoblastic Leukemia
Intervention Biological: cellular immunotherapy
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cellular Immunotherapy
Hide Arm/Group Description

A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.

cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.

Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Cellular Immunotherapy
Hide Arm/Group Description

A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.

cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  40.0%
>=65 years
3
  60.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
66.2
(52 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.
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Criteria for AML and ALL (adapted from Cheson et al.20)

Complete remission (CR) is defined as the presence of all of the following

  • Peripheral blood

    o No leukemic blasts present.

  • No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)
  • Bone marrow

    • Cellularity >20% with baseline maturation.
    • No Auer rods
    • Less than 5% blast cells.
  • Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC > 1.0 x 109/L and platelet count > 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free.

Complete remission with incomplete recovery (CRi) is defined as the following:

  • Meets criteria for CR except
  • ANC < 1.0 x 109/L or platelet count < 100x109/L

Partial remission (PR).

• Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts.

Time Frame 8 weeks after infusion then 6 months after and every 4 months for approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cellular Immunotherapy
Hide Arm/Group Description:

A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.

cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title To Evaluate the Rate of Dose Limiting Toxicities of HLA Haploidentical Peripheral Blood Pheresed Cellular Infusions.
Hide Description [Not Specified]
Time Frame 30 days and 16 weeks after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cellular Immunotherapy
Hide Arm/Group Description:

A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.

cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cellular Immunotherapy
Hide Arm/Group Description

A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.

cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.

All-Cause Mortality
Cellular Immunotherapy
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Cellular Immunotherapy
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Investigations   
Albumin  1/6 (16.67%)  1
ALT  1/6 (16.67%)  1
anemia  2/6 (33.33%)  2
AST  1/6 (16.67%)  1
bone pain  1/6 (16.67%)  1
ca  1/6 (16.67%)  1
CRS (pt 3 included n, ha, r)  1/6 (16.67%)  1
diarrhea  1/6 (16.67%)  1
dizziness  4/6 (66.67%)  4
Febrile Neutropenia  1/6 (16.67%)  1
fever  2/6 (33.33%)  2
Hypotension  3/6 (50.00%)  3
tachycardia  1/6 (16.67%)  1
infection  1/6 (16.67%)  1
  1/6 (16.67%)  1
Nausea  1/6 (16.67%)  1
Neutropenia  1/6 (16.67%)  1
pain-neck  1/6 (16.67%)  1
PLT  1/6 (16.67%)  1
creatinine  1/6 (16.67%)  1
infection: wound  1/6 (16.67%)  2
GI bleed  1/6 (16.67%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cellular Immunotherapy
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Investigations   
alk phos  1/6 (16.67%)  1
anemia  4/6 (66.67%)  4
anxiety  1/6 (16.67%)  1
arthralgia  1/6 (16.67%)  1
bleeding scrotum  1/6 (16.67%)  1
bone pain  1/6 (16.67%)  1
ca  2/6 (33.33%)  2
diarrhea  1/6 (16.67%)  1
cough  2/6 (33.33%)  2
edema  2/6 (33.33%)  2
epistaxis  1/6 (16.67%)  1
erythema  1/6 (16.67%)  1
eye stye Not graded pt 3  2/6 (33.33%)  2
fever  2/6 (33.33%)  2
Hyperglycemia  5/6 (83.33%)  5
1/6 (16.67%)  1
Leukocytosis  1/6 (16.67%)  1
Lymph  4/6 (66.67%)  4
minor bleeding superficila leg lesions "minor" NG pt #3  1/6 (16.67%)  1
  2/6 (33.33%)  2
Neutropenia  3/6 (50.00%)  3
oral thrush  1/6 (16.67%)  1
Phos  2/6 (33.33%)  2
PLT  1/6 (16.67%)  1
post nasal  1/6 (16.67%)  1
segs/neuts  1/6 (16.67%)  1
sinus pain Not graded pt 3  1/6 (16.67%)  1
sinus tach  1/6 (16.67%)  1
Vomiting  1/6 (16.67%)  1
WBC  2/6 (33.33%)  2
cellulitis  1/6 (16.67%)  1
fatigue  1/6 (16.67%)  1
LE pain  1/6 (16.67%)  1
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: Dr. Peter Quesenberry
Organization: Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
EMail: kayla_rosati@brown.edu
Layout table for additonal information
Responsible Party: Peter Quesenberry, Brown University
ClinicalTrials.gov Identifier: NCT01685606    
Other Study ID Numbers: BrUOG 273
First Submitted: September 12, 2012
First Posted: September 14, 2012
Results First Submitted: June 4, 2015
Results First Posted: June 26, 2015
Last Update Posted: August 11, 2015