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Trial record 13 of 23 for:    CD20 Fred Hutchinson

Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells

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ClinicalTrials.gov Identifier: NCT01097057
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : July 2, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leona Holmberg, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin Lymphoma
Interventions Drug: Carboplatin
Drug: Etoposide
Biological: Filgrastim
Drug: Ifosfamide
Procedure: Leukapheresis
Drug: Plerixafor
Biological: Rituximab
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Hide Arm/Group Description

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Carboplatin: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Ifosfamide: Given IV

Leukapheresis: Given through catheter

Plerixafor: Given SC

Rituximab: Given IV

Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Reason Not Completed
Physician Decision             3
Arm/Group Title Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
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Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Carboplatin: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Ifosfamide: Given IV

Leukapheresis: Given through catheter

Plerixafor: Given SC

Rituximab: Given IV

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  40.0%
>=65 years
12
  60.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
66
(42 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
6
  30.0%
Male
14
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)
Hide Description Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis.
Time Frame One Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Hide Arm/Group Description:

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Carboplatin: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Ifosfamide: Given IV

Leukapheresis: Given through catheter

Plerixafor: Given SC

Rituximab: Given IV

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
 100.0%
2.Primary Outcome
Title Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days
Hide Description Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures.
Time Frame Up to Four Apheresis Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Hide Arm/Group Description:

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Carboplatin: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Ifosfamide: Given IV

Leukapheresis: Given through catheter

Plerixafor: Given SC

Rituximab: Given IV

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
 100.0%
3.Primary Outcome
Title Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
Hide Description Number of participants requiring one or two apheresis collection days to reach collection goal.
Time Frame Up to Four Apheresis Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Hide Arm/Group Description:

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Carboplatin: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Ifosfamide: Given IV

Leukapheresis: Given through catheter

Plerixafor: Given SC

Rituximab: Given IV

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
One apheresis collection day
15
  88.2%
Two apheresis collection days
2
  11.8%
Three apheresis collection days
0
   0.0%
Four apheresis collection days
0
   0.0%
4.Primary Outcome
Title Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days
Hide Description Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days
Time Frame Up to Four Apheresis Days
Hide Outcome Measure Data
Hide Analysis Population Description
Note: No patients were in this category.
Arm/Group Title Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Hide Arm/Group Description:

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Carboplatin: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Ifosfamide: Given IV

Leukapheresis: Given through catheter

Plerixafor: Given SC

Rituximab: Given IV

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Hide Arm/Group Description

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Carboplatin: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Ifosfamide: Given IV

Leukapheresis: Given through catheter

Plerixafor: Given SC

Rituximab: Given IV

All-Cause Mortality
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Affected / at Risk (%)
Total   5/20 (25.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Affected / at Risk (%)
Total   2/20 (10.00%) 
Blood and lymphatic system disorders   
Febrile Neutropenia  [1]  1/20 (5.00%) 
Cardiac disorders   
Atrial Fibrillation  [1]  1/20 (5.00%) 
Indicates events were collected by systematic assessment
[1]
No treatment related deaths
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)
Affected / at Risk (%)
Total   3/20 (15.00%) 
Infections and infestations   
Cellulitis  [1]  1/20 (5.00%) 
Metabolism and nutrition disorders   
Hyperglycemia  [2]  2/20 (10.00%) 
Vascular disorders   
DVT  [3]  1/20 (5.00%) 
Indicates events were collected by systematic assessment
[1]
Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. Cellulitis at Hickman site
[2]
Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. One patient had both hyperglycemia and cellulitis.
[3]
Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. Asymptomatic line-associated DVT requiring therapeutic anticoagulant.
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. Leona A. Holmberg
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-6447
EMail: lholmber@fredhutch.org
Layout table for additonal information
Responsible Party: Leona Holmberg, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01097057     History of Changes
Other Study ID Numbers: 2310.00
NCI-2009-01562 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2310.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: March 30, 2010
First Posted: April 1, 2010
Results First Submitted: March 26, 2017
Results First Posted: July 2, 2017
Last Update Posted: January 23, 2018