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Trial record 22 of 29 for:    " July 17, 2011":" August 16, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Allogeneic Transplant in HIV Patients (BMT CTN 0903)

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ClinicalTrials.gov Identifier: NCT01410344
Recruitment Status : Active, not recruiting
First Posted : August 5, 2011
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
HIV
Interventions: Drug: Fludarabine and Busulfan
Drug: Fludarabine and Melphalan
Drug: Busulfan and Fludarabine
Drug: Cyclophosphamide and Total Body Irradiation

  Participant Flow

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
Allogeneic Transplant One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).

Participant Flow:   Overall Study
    Allogeneic Transplant
STARTED   20 
COMPLETED   17 
NOT COMPLETED   3 



  Baseline Characteristics

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.
Transplanted participants

Reporting Groups
  Description
Allogeneic Transplant One regimen from either reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) or myeloablative conditioning (MAC) (Busulfan and Fludarabine; or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).

Baseline Measures
   Allogeneic Transplant 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed   17 
   47 
 (25 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
Female      0   0.0% 
Male      17 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
Hispanic or Latino      1   5.9% 
Not Hispanic or Latino      15  88.2% 
Unknown or Not Reported      1   5.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
American Indian or Alaska Native      1   5.9% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3  17.6% 
White      11  64.7% 
More than one race      0   0.0% 
Unknown or Not Reported      2  11.8% 
Karnofsky Performance Score [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
100      4  23.5% 
90      9  52.9% 
80      3  17.6% 
70      1   5.9% 
[1] Assesses patient self-perceived global quality of life and functioning, where 100 equals perfect quality of life.
Primary Malignancy 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
Acute Myeloid Leukemia (AML)      9  52.9% 
Acute Lymphocytic Leukemia (ALL)      2  11.8% 
Myelodysplastic Syndromes (MDS)      2  11.8% 
Hodgkin's Lymphoma      1   5.9% 
Non-Hodgkin's Lymphoma      3  17.6% 
Leukemia Stage [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   11 
First Complete Remission      8  72.7% 
Second Complete Remission      3  27.3% 
[1] Participants with leukemia (AML or ALL)
Lymphoma Stage [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   4 
Complete Remission      3  75.0% 
Partial Remission      1  25.0% 
[1] Participants with lymphoma (Hodgkin's or non-Hodgkin's)
HIV Viral Load 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
Undetectable by Assay      15  88.2% 
Detectable by Assay      2  11.8% 
Recipient Cytomegalovirus Status 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
Positive      12  70.6% 
Negative      5  29.4% 
Number of Regimens of Induction Chemotherapy 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
    10  58.8% 
    6  35.3% 
    1   5.9% 
Number of Regimens of Salvage Chemotherapy 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
    10  58.8% 
    6  35.3% 
    1   5.9% 
Donor Type [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed   17 
Matched Related      4  23.5% 
Matched Unrelated      9  52.9% 
Mismatched Related      3  17.6% 
Mismatched Unrelated      1   5.9% 
[1] Donor/recipient matching described by relatedness and HLA matching. A matched donor corresponds to matching on 8/8 HLA loci, while mismatched donor indicates 7/8 matching.
CD4 T-cell Count 
[Units: Cells/microliter]
Median (Full Range)
 
Participants Analyzed   17 
   224 
 (55 to 833) 


  Outcome Measures

1.  Primary:   Percentage of Participants With Non-Relapse Mortality   [ Time Frame: 100 days post-transplant ]

2.  Secondary:   Disease Status Following Transplant   [ Time Frame: 100 days ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

3.  Secondary:   Chimerism   [ Time Frame: 4 weeks, 100 days and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

4.  Secondary:   Incidence of Infections   [ Time Frame: Date of transplant through one year post-transplant ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

5.  Secondary:   Six Month Overall Survival   [ Time Frame: Six months post transplant ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

6.  Secondary:   Acute Graft-versus-Host Disease (GVHD)   [ Time Frame: 100 Days ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

7.  Secondary:   Chronic Graft-versus-Host Disease (GVHD)   [ Time Frame: 100 days, 6 months, 2 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

8.  Secondary:   Immunologic Reconstitution   [ Time Frame: 8 Weeks; 6, 12 and 24 Months ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

9.  Secondary:   Impact of Therapy on the HIV Reservoir   [ Time Frame: Day 100, 6 Months, 12 Months, and 24 Months ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

10.  Secondary:   Hematologic Function   [ Time Frame: Day 100, 6 months ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: NCT01410344     History of Changes
Other Study ID Numbers: BMTCTN0903
U01HL069294 ( U.S. NIH Grant/Contract )
BMT CTN 0903 ( Other Identifier: Blood and Marrow Transplant Clinical Trials Network )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2011
First Posted: August 5, 2011
Results First Submitted: March 26, 2018
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018