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Autologous Transplant in HIV Patients (BMT CTN 0803)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01141712
First Posted: June 10, 2010
Last Update Posted: March 28, 2017
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.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin
Results First Submitted: August 10, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma
HIV
Interventions: Procedure: Autologous transplant
Drug: BCNU
Drug: Etoposide
Drug: Cytarabine
Drug: Melphalan

  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 2010 and March 2013 from 16 different transplant centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three patients did not undergo transplantation due to disease progression prior to conditioning.

Reporting Groups
  Description
Autologous Transplant Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day from Days -5 to -2, Cytarabine 100 mg/m^2 twice a day from Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.

Participant Flow:   Overall Study
    Autologous Transplant
STARTED   43 
COMPLETED   40 
NOT COMPLETED   3 
Disease progression                3 



  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.
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Reporting Groups
  Description
Autologous Transplant Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day (BID) on Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.

Baseline Measures
   Autologous Transplant 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 46.9 
 (22.5 to 62.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  12.5% 
Male      35  87.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      9  22.5% 
Not Hispanic or Latino      29  72.5% 
Unknown or Not Reported      2   5.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black or African American   13 
White   24 
Unknown   3 
Karnofsky Performance Score [1] 
[Units: Participants]
 
100   11 
90   20 
80   7 
70   2 
[1] Measure Description: 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, 80 equals normal activity with effort and some signs/symptoms of disease, and 70 equals ability to care for self but unable to carry on normal activity or to do active work.
Participant Diagnosis 
[Units: Participants]
 
Hodgkin's Lymphoma   15 
Diffuse Large B-cell Lymphoma   16 
Plasmablastic Lymphoma   2 
Burkitt's Lymphoma   7 
Disease Status 
[Units: Participants]
 
Complete Remission   30 
Partial Remission   9 
Relapsed or Progressive Disease   1 


  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Year 1 and 2 ]

2.  Secondary:   Relapse/Progression   [ Time Frame: Year 2 ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Year 2 ]

4.  Secondary:   Complete Remission (CR) and/or Partial Response (PR)   [ Time Frame: Day 100 ]

5.  Secondary:   Time to Progression After CR   [ Time Frame: Year 2 ]

6.  Secondary:   Lymphoma Disease-free Survival   [ Time Frame: Year 2 ]

7.  Secondary:   Cumulative Incidence of Neutrophil Recovery   [ Time Frame: Day 28 ]

8.  Secondary:   Cumulative Incidence of Platelet Recovery   [ Time Frame: Day 100 ]

9.  Secondary:   Hematologic Function   [ Time Frame: Days 100 and 365 ]

10.  Secondary:   Number of Participants Experiencing Toxicity   [ Time Frame: Year 2 ]

11.  Secondary:   Number of Participants Experiencing Infections   [ Time Frame: Year 1 ]

12.  Secondary:   Treatment-Related Mortality (TRM)   [ Time Frame: Day 100 ]

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

14.  Secondary:   HIV Single-Copy Polymerase Chain Reaction (PCR)   [ Time Frame: Baseline, Days 100, 180, 365, and 730 ]

15.  Secondary:   Microbial Translocation Markers   [ Time Frame: Day 30 and 100 ]

16.  Secondary:   Ig and Epstein-Barr Virus (EBV) DNA in Blood   [ Time Frame: Day 100, 180, 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
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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: 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: NCT01141712     History of Changes
Other Study ID Numbers: BMTCTN0803
U01HL069294 ( U.S. NIH Grant/Contract )
U01HL069294-06 ( U.S. NIH Grant/Contract )
U01CA121947 ( U.S. NIH Grant/Contract )
First Submitted: June 9, 2010
First Posted: June 10, 2010
Results First Submitted: August 10, 2016
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017