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Blood Stem Cell Transplant With Low Dose Chemotherapy for Relapsed Follicular Non-Hodgkin's Lymphoma (BMT CTN 0701)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00912223
First received: June 1, 2009
Last updated: September 30, 2016
Last verified: September 2016
Results First Received: August 5, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma, Non-Hodgkin
Intervention: Biological: Hematopoietic Stem Cell Transplant

  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
Participants were enrolled between April 2009 and November 2012 from 21 different transplant centers.

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
Hematopoietic Stem Cell Transplant Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.

Participant Flow:   Overall Study
    Hematopoietic Stem Cell Transplant
STARTED   65 
COMPLETED   62 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Not transplanted                1 
Transformed disease                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.
Received transplant

Reporting Groups
  Description
Hematopoietic Stem Cell Transplant Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.

Baseline Measures
   Hematopoietic Stem Cell Transplant 
Overall Participants Analyzed 
[Units: Participants]
 62 
Age 
[Units: Years]
Median (Full Range)
 55 
 (29 to 74) 
Gender 
[Units: Participants]
 
Female   23 
Male   39 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   58 
Not Hispanic or Latino   4 
Unknown or Not Reported   0 
Karnofsky Performance Score [1] 
[Units: Participants]
 
100   29 
90   28 
80   5 
[1] Assesses patient self-perceived global quality of life and functioning on a scale of 0 - 100; where 100 equals normal quality of life with no evidence of disease, 90 equals ability to carry on normal activity with minor signs/symptoms of disease, and 80 equals normal activity with effort and some signs/symptoms of disease.
Comorbidity Index Score [1] 
[Units: Participants]
 
 31 
1-2   16 
>3   15 
[1] Comorbidity is graded on a scale of 0 to 6 based on the adjusted risk of mortality and the sum of scores result in a single comorbidity index score for a participant. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality.
Disease Status [1] 
[Units: Participants]
 
CR2   32 
PR1   6 
≥ PR2   16 
Stable Disease   2 
Unknown   6 
[1] Disease status is categorized best to worst by second/subsequent complete remission (CR2), first partial remission (PR1), second partial remission (PR2). Complete remission criteria is disappearance of all evidence of disease and partial remission criteria is regression of measurable disease and no new sites.
Number of Prior Chemotherapy Regimens 
[Units: Participants]
 
 14 
 16 
 12 
≥ 5   20 
Donor Type (HLA match) 
[Units: Participants]
 
Matched Related Donor (6/6 allele)   33 
Matched Unrelated Donor (8/8 allele)   29 
Recipient Cytomegalovirus Status 
[Units: Participants]
 
Positive   35 
Negative   27 


  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Year 2 ]

2.  Secondary:   Graft Failure   [ Time Frame: Day 30 ]

3.  Secondary:   Donor Cell Engraftment   [ Time Frame: Days 30 and 100 ]

4.  Secondary:   Time to Neutrophil Recovery   [ Time Frame: Day 60 ]

5.  Secondary:   Acute Graft-versus-Host Disease (GVHD)   [ Time Frame: Day 100 ]

6.  Secondary:   Chronic GVHD   [ Time Frame: Year 2 ]

7.  Secondary:   Overall Survival   [ Time Frame: Years 2 and 3 ]

8.  Secondary:   Treatment-related Mortality (TRM)   [ Time Frame: Year 3 ]

9.  Secondary:   Infections   [ Time Frame: Year 2 ]

10.  Secondary:   Quality of Life   [ Time Frame: Year 2 ]

11.  Secondary:   Immunologic Reconstitution   [ Time Frame: Year 1 ]

12.  Secondary:   Incidence of Toxicities   [ Time Frame: Year 2 ]

13.  Secondary:   Serum Rituximab (RTX) Levels   [ Time Frame: Baseline, Days 28 and 365 ]


  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
No text entered.


  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: Adam Mendizabal, PhD
Organization: The Emmes Corporation
phone: 301-251-1161
e-mail: amendizabal@emmes.com


Publications of Results:

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00912223     History of Changes
Obsolete Identifiers: NCT00867074
Other Study ID Numbers: BMTCTN0701
U01HL069294 ( US NIH Grant/Contract Award Number )
U01HL06929406 ( Other Identifier: National Cancer Institute (NCI) )
5U24CA076518 ( US NIH Grant/Contract Award Number )
Study First Received: June 1, 2009
Results First Received: August 5, 2016
Last Updated: September 30, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board