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Allogeneic Transplant in HIV Patients (BMT CTN 0903)

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ClinicalTrials.gov Identifier: NCT01410344
Recruitment Status : Completed
First Posted : August 5, 2011
Results First Posted : May 24, 2018
Last Update Posted : December 27, 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 Day 100, 1 Year, and 2 Years 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
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 100
0.0
(0.0 to 0.0)
1 Year
11.8
(1.8 to 32.2)
2 Years
18.3
(4.1 to 40.7)
2.Secondary Outcome
Title Percentage of Participants With Overall Survival
Hide Description Overall survival is defined as the time from transplant to death from any cause.
Time Frame Six months, 1 Year, and 2 Years 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
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6 Months
82.4
(54.7 to 93.9)
1 Year
58.8
(32.5 to 77.8)
2 Years
50.2
(24.3 to 71.4)
3.Secondary Outcome
Title Percentage of Participants With Relapse/Progression
Hide Description Relapse/Progression is defined as relapse or progression of the primary malignancy.
Time Frame 1 Year 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
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.4
(10.2 to 51.9)
4.Secondary Outcome
Title Primary Cause of Death
Hide Description [Not Specified]
Time Frame Up to 2 Years 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: Count of Participants
Unit of Measure: Participants
Relapse/Progresion
5
  29.4%
Acute GVHD
1
   5.9%
Adult Respiratory Distress Syndrome
1
   5.9%
Liver Failure
1
   5.9%
Still Alive
9
  52.9%
5.Secondary Outcome
Title Disease Status
Hide Description Patients will be assessed for disease status at Day 100 post-HCT, classified as complete remission, partial remission, stable disease, and relapse/progressive disease.
Time Frame Day 100 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: Count of Participants
Unit of Measure: Participants
Complete remission
13
  76.5%
Relapse/progressive disease
4
  23.5%
6.Secondary Outcome
Title Percentage of Participants Recovering Hematologic Function
Hide Description Recovery of hematologic function is described by the time to neutrophil and platelet recovery. Time to neutrophil recovery will be the first of three consecutive days of > 500 neutrophils/μL following the expected nadir. Time to platelet engraftment will be described by the date when platelet count is > 20,000/μL for the first of three consecutive labs with no platelet transfusions 7 days prior.
Time Frame Days 28 and 100 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
Day 28 Neutrophil Recovery 100.0
Day 100 Platelet Recovery 94.1
7.Secondary Outcome
Title Chimerism
Hide Description Donor T-cell and myeloid chimerism will be described separately by conditioning regimen intensity (myeloablative or reduced intensity) according to proportions with mixed chimerism (5-95% donor cells out of all), full chimerism (>95% donor cells), or graft rejection (<5% donor cells).
Time Frame Week 4, Day 100, and 6 months Post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myeloablative Allogeneic Transplant Reduced Intensity Allogeneic Transplant
Hide Arm/Group Description:
Myeloablative conditioning (MAC) (Busulfan and Fludarabine or Cyclophosphamide and Total Body Irradiation) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
Reduced-intensity conditioning (RIC) (Fludarabine and Busulfan; or Fludarabine and Melphalan) will be administered prior to allogeneic hematopoietic cell transplantation (HCT).
Overall Number of Participants Analyzed 8 9
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Full Chimerism
4
  50.0%
5
  55.6%
Mixed Chimerism
2
  25.0%
4
  44.4%
Graft Rejection
1
  12.5%
0
   0.0%
Dead at Assessment
0
   0.0%
0
   0.0%
No Assay Reported
1
  12.5%
0
   0.0%
Day 100 Full Chimerism
3
  37.5%
5
  55.6%
Mixed Chimerism
4
  50.0%
4
  44.4%
Graft Rejection
0
   0.0%
0
   0.0%
Dead at Assessment
1
  12.5%
0
   0.0%
No Assay Reported
0
   0.0%
0
   0.0%
6 Months Full Chimerism
4
  50.0%
5
  55.6%
Mixed Chimerism
2
  25.0%
2
  22.2%
Graft Rejection
0
   0.0%
0
   0.0%
Dead at Assessment
2
  25.0%
2
  22.2%
No Assay Reported
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD)
Hide Description

Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:

Skin stage:

0: No rash

  1. Rash <25% of body surface area
  2. Rash on 25-50% of body surface area
  3. Rash on > 50% of body surface area
  4. Generalized erythroderma with bullous formation

Liver stage (based on bilirubin level)*:

0: <2 mg/dL 1.2-3 mg/dL 2.3.01-6 mg/dL 3.6.01-15.0 mg/dL 4.>15 mg/dL

GI stage*:

0: No diarrhea or diarrhea <500 mL/day

  1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD
  2. Diarrhea 1000-1499 mL/day
  3. Diarrhea >1500 mL/day
  4. Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.

GVHD grade:

0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4

Time Frame Day 100 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
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Grade II-IV Acute GVHD
41.2
(17.8 to 63.4)
Grade III-IV Acute GVHD
11.8
(1.8 to 31.9)
9.Secondary Outcome
Title Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD)
Hide Description Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification.
Time Frame 1 Year 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
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.6
(4.0 to 39.2)
10.Secondary Outcome
Title Infection Severity
Hide Description The maximum grade of infections reported by participants are described, as defined in the BMT CTN Technical MOP.
Time Frame 1 Year 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: Count of Participants
Unit of Measure: Participants
Grade 0-1
6
  35.3%
Grade 2
3
  17.6%
Grade 3
8
  47.1%
Time Frame Up to 2 Years Post-transplant
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   8/20 (40.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Allogeneic Transplant
Affected / at Risk (%) # Events
Total   5/20 (25.00%)    
Cardiac disorders   
Supraventricular tachycardia  1/20 (5.00%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1/20 (5.00%)  1
Small intestinal obstruction  1/20 (5.00%)  3
Upper gastrointestinal haemorrhage  1/20 (5.00%)  1
Hepatobiliary disorders   
Hepatic failure  1/20 (5.00%)  1
Infections and infestations   
Sepsis  1/20 (5.00%)  1
Investigations   
Hepatic enzyme increased  1/20 (5.00%)  1
Metabolism and nutrition disorders   
Hyperkalaemia  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1/20 (5.00%)  1
Vascular disorders   
Hypotension  1/20 (5.00%)  1
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 (%) # Events
Total   0/20 (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: December 27, 2018