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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
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Allogeneic Transplant
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Arm/Group Title Allogeneic Transplant
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
Transplanted participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
47
(25 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
0
   0.0%
Male
17
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Hispanic or Latino
1
   5.9%
Not Hispanic or Latino
15
  88.2%
Unknown or Not Reported
1
   5.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
100
4
  23.5%
90
9
  52.9%
80
3
  17.6%
70
1
   5.9%
[1]
Measure Description: Assesses patient self-perceived global quality of life and functioning, where 100 equals perfect quality of life.
Primary Malignancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
First Complete Remission
8
  72.7%
Second Complete Remission
3
  27.3%
[1]
Measure Analysis Population Description: Participants with leukemia (AML or ALL)
Lymphoma Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Complete Remission
3
  75.0%
Partial Remission
1
  25.0%
[1]
Measure Analysis Population Description: Participants with lymphoma (Hodgkin's or non-Hodgkin's)
HIV Viral Load  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Undetectable by Assay
15
  88.2%
Detectable by Assay
2
  11.8%
Recipient Cytomegalovirus Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Positive
12
  70.6%
Negative
5
  29.4%
Number of Regimens of Induction Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
1
10
  58.8%
2
6
  35.3%
3
1
   5.9%
Number of Regimens of Salvage Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
0
10
  58.8%
1
6
  35.3%
3
1
   5.9%
Donor Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Matched Related
4
  23.5%
Matched Unrelated
9
  52.9%
Mismatched Related
3
  17.6%
Mismatched Unrelated
1
   5.9%
[1]
Measure Description: 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  
Median (Full Range)
Unit of measure:  Cells/microliter
Number Analyzed 17 participants
224
(55 to 833)
1.Primary Outcome
Title Percentage of Participants With Non-Relapse Mortality
Hide Description The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy.
Time Frame 100 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allogeneic Transplant
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of participants
100.0
2.Secondary Outcome
Title Disease Status Following Transplant
Hide Description Patients will be assessed for disease status at Day 100 post-HCT: complete remission, partial remission (HL, NHL), stable disease (HL, NHL), relapse.
Time Frame 100 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Chimerism
Hide Description Blood samples will be evaluated for T cell and myeloid chimerism at 4 weeks, 100 days and 6 months post-transplant.
Time Frame 4 weeks, 100 days and 6 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Incidence of Infections
Hide Description Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any.
Time Frame Date of transplant through one year post-transplant
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Six Month Overall Survival
Hide Description Overall survival is defined as time from transplant to death or last follow-up.
Time Frame Six months post transplant
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Acute Graft-versus-Host Disease (GVHD)
Hide Description Acute GVHD will be graded according to the BMT CTN Manual of Procedures. The time to onset of acute grades II-IV GVHD and grades III-IV GVHD will be recorded, as well as the maximum grade achieved.
Time Frame 100 Days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Chronic Graft-versus-Host Disease (GVHD)
Hide Description Chronic GVHD will be scored according to the BMT CTN Manual of Procedures. The time to onset of limited and extensive chronic GVHD will be recorded.
Time Frame 100 days, 6 months, 2 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Immunologic Reconstitution
Hide Description This will be measured in all patients at 8 weeks, 6 months, 12 months and 24 months post-transplant. Tests to be performed on peripheral blood at those time points include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-, and quantitative immunoglobulins (IgM, IgG and IgA).
Time Frame 8 Weeks; 6, 12 and 24 Months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Impact of Therapy on the HIV Reservoir
Hide Description HIV-1 RNA in plasma will be measured by standard real-time reverse transcription polymerase chain reaction (RT-PCR) (detection limit 40 copies/ml) and by the investigational single copy assay (SCA, detection limit 0.38 copy/ml). HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) and other cells will be quantified using the same primers and probes used for SCA but without a reverse transcription step. HIV-1 RNA levels will be measured in plasma prior to the initiation of ablative chemotherapy, and at Day +100, 1 and 2 years post-transplant.
Time Frame Day 100, 6 Months, 12 Months, and 24 Months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Hematologic Function
Hide Description Hematologic function will be defined by absolute neutrophil count (ANC) greater than 1500, Hemoglobin greater than 10g/dL without transfusion support, and platelets greater than 100,000 and measured at Day 100 and 6 months. Use of growth factors will be noted.
Time Frame Day 100, 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Allogeneic Transplant
Hide Arm/Group Description 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).
All-Cause Mortality
Allogeneic Transplant
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Allogeneic Transplant
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Allogeneic Transplant
Affected / at Risk (%)
Total   0/17 (0.00%) 
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
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