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

This study has been terminated.
(lower than anticipated accrual)
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00096460
First received: November 9, 2004
Last updated: February 22, 2013
Last verified: February 2013
Results First Received: August 16, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Grades 1-3 Follicular Lymphoma
Follicular Lymphoma
Interventions: Drug: carmustine
Drug: cyclophosphamide
Drug: etoposide
Drug: filgrastim
Drug: fludarabine
Drug: methotrexate
Drug: rituximab
Drug: tacrolimus
Procedure: bone marrow ablation with stem cell support
Procedure: chemotherapy
Procedure: graft versus host disease (GVHD) prophylaxis/therapy
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Procedure: supportive care/therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Autologous Hematopoietic Stem Cell Transplant (HSCT) 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
Allogeneic Hematopoietic Stem Cell Transplant (HSCT) 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)

Participant Flow:   Overall Study
    Autologous Hematopoietic Stem Cell Transplant (HSCT)     Allogeneic Hematopoietic Stem Cell Transplant (HSCT)  
STARTED     22     8  
COMPLETED     15     7  
NOT COMPLETED     7     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Autologous Hematopoietic Stem Cell Transplant (HSCT) 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
Allogeneic Hematopoietic Stem Cell Transplant (HSCT) 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 Total of all reporting groups

Baseline Measures
    Autologous Hematopoietic Stem Cell Transplant (HSCT)     Allogeneic Hematopoietic Stem Cell Transplant (HSCT)     Total  
Number of Participants  
[units: participants]
  22     8     30  
Age  
[units: years]
Median ( Full Range )
  50  
  ( 36 to 66 )  
  48  
  ( 40 to 64 )  
  49  
  ( 36 to 66 )  
Gender  
[units: participants]
     
Female     12     3     15  
Male     10     5     15  
Region of Enrollment  
[units: participants]
     
United States     22     8     30  
Disease Status at Enrollment  
[units: 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  
[units: Number¬†of¬†therapies]
Median ( Full Range )
  2  
  ( 1 to 3 )  
  2  
  ( 1 to 3 )  
  2  
  ( 1 to 3 )  
Months from diagnosis to transplant  
[units: months]
Median ( Full Range )
  39.8  
  ( 9.8 to 110.5 )  
  28.9  
  ( 16.2 to 64.7 )  
  33.6  
  ( 9.8 to 110.5 )  



  Outcome Measures

1.  Primary:   Lymphoma Progression-free Survival   [ Time Frame: Three years post-Hematopoietic Stem Cell Transplant (HSCT) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Steve Wease
Organization: The EMMES Corporation
e-mail: swease@emmes.com


Publications of Results:

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00096460     History of Changes
Other Study ID Numbers: 419, U01HL069294, BMTCTN-0202, FMLH-04-143, HRRC-301-04
Study First Received: November 9, 2004
Results First Received: August 16, 2011
Last Updated: February 22, 2013
Health Authority: United States: Federal Government