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Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)

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ClinicalTrials.gov Identifier: NCT00096460
Recruitment Status : Terminated (lower than anticipated accrual)
First Posted : November 10, 2004
Results First Posted : September 17, 2012
Last Update Posted : September 12, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Follicular Lymphoma
Interventions Drug: Cyclophosphamide and Rituximab
Drug: Filgrastim
Radiation: Chemotherapy or Radiation therapy
Drug: Non-myeloablative Conditioning regimen
Procedure: Allogeneic transplant
Procedure: Autologous transplant
Drug: Rituximab maintenance therapy
Drug: GVHD Prophylaxis
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autologous Hematopoietic Stem Cell Transplant (HSCT) Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Hide Arm/Group Description Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
Period Title: Overall Study
Started 22 8
Completed 15 7
Not Completed 7 1
Arm/Group Title Autologous Hematopoietic Stem Cell Transplant (HSCT) Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Total
Hide Arm/Group Description Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4) Total of all reporting groups
Overall Number of Baseline Participants 22 8 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 8 participants 30 participants
50
(36 to 66)
48
(40 to 64)
49
(36 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 8 participants 30 participants
Female
12
  54.5%
3
  37.5%
15
  50.0%
Male
10
  45.5%
5
  62.5%
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 8 participants 30 participants
22 8 30
Disease Status at Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 8 participants 30 participants
First Relapse 2 0 2
Second Relapse 1 0 1
Third Relapse 1 0 1
Second Partial Remission 8 3 11
Third Partial Remission 3 1 4
Second Complete Remission 6 3 9
Third Complete Remission 1 1 2
Number of Prior Therapies  
Median (Full Range)
Unit of measure:  Number of therapies
Number Analyzed 22 participants 8 participants 30 participants
2
(1 to 3)
2
(1 to 3)
2
(1 to 3)
Months from diagnosis to transplant  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 22 participants 8 participants 30 participants
39.8
(9.8 to 110.5)
28.9
(16.2 to 64.7)
33.6
(9.8 to 110.5)
1.Primary Outcome
Title Lymphoma Progression-free Survival
Hide Description [Not Specified]
Time Frame Three years post-Hematopoietic Stem Cell Transplant (HSCT)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous Hematopoietic Stem Cell Transplant (HSCT) Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Hide Arm/Group Description:
Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
Overall Number of Participants Analyzed 20 7
Measure Type: Number
Unit of Measure: participants
13 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autologous Hematopoietic Stem Cell Transplant (HSCT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Survival Probability
Estimated Value 62.7
Confidence Interval (2-Sided) 95%
43.8 to 89.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Survival Probability
Estimated Value 85.7
Confidence Interval 95%
63.3 to 100
Estimation Comments [Not Specified]
Time Frame 3-years post-transplant
Adverse Event Reporting Description Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
 
Arm/Group Title Autologous Hematopoietic Stem Cell Transplant (HSCT) Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Hide Arm/Group Description Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
All-Cause Mortality
Autologous Hematopoietic Stem Cell Transplant (HSCT) Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Autologous Hematopoietic Stem Cell Transplant (HSCT) Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autologous Hematopoietic Stem Cell Transplant (HSCT) Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/7 (14.29%)    
Respiratory, thoracic and mediastinal disorders     
Dyspnoea exertional * 1  0/20 (0.00%)  0 1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v12.0
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
Name/Title: Adam Mendizabal, PhD
Organization: The EMMES Corporation
Phone: (301) 251-1161 ext 221
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00096460     History of Changes
Other Study ID Numbers: BMTCTN0202
U01HL069294 ( U.S. NIH Grant/Contract )
BMT CTN 0202 ( Other Identifier: Blood and Marrow Transplant Clinical Trials Network )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 10, 2004
Results First Submitted: August 16, 2011
Results First Posted: September 17, 2012
Last Update Posted: September 12, 2016