Sponsor study identifier
Secondary identifiers
NIH
OTHER · Blood and Marrow Transplant Clinical Trials Network
NIH
interventional
20
1 country
11
Study Start
September 2011
Actual (reported)Primary Completion
November 2016
Actual (reported)Study Completion
June 2018
Actual (reported)The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes for the delta32 mutation for CCR5.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2011
Actual (reported)August 5, 2011
Actual (reported)September 2011
Actual (reported)November 2016
Actual (reported)May 24, 2018
Actual (reported)June 2018
Actual (reported)Percentage of Participants With Non-Relapse Mortality
The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy.
Day 100, 1 Year, and 2 Years Post-transplant
Percentage of Participants With Overall Survival
Six months, 1 Year, and 2 Years Post-transplant
Percentage of Participants With Relapse/Progression
1 Year Post-transplant
Primary Cause of Death
Up to 2 Years Post-transplant
Disease Status
Day 100 Post-transplant
Percentage of Participants Recovering Hematologic Function
Days 28 and 100 Post-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).
RIC Regimen (Flu/Bu): Fludarabine total dose: 120-180 mg/m\^2, Busulfan: ≤ 8 mg/kg PO or 6.4 mg/kg IV). Recommended regimen: * Days -6 to -2: Flu (30 mg/m\^2/day, total dose of 150 mg/m\^2) * Days -5 to -4: Busulfan (4mg/kg/day PO or 3.2 mg/kg IV, 130 mg/m\^2/day, total dose of 8 mg/kg PO or 6.4 mg/kg IV, or 260 mg/m\^2 IV, respectively) Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage. Busulfan will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125 percent of IBW, in which case the drug will be dosed according to the adjusted IBW.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Fludarabine and Busulfan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Fludarabine and Melphalan
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Busulfan and Fludarabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordTreatment and procedure
Cyclophosphamide and Total Body Irradiation
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordMayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of CA, SF
San Francisco, California, 94143-0324, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Blood & Marrow Transplant Program at Northside Hospital
Atlanta, Georgia, 30342, United States
Johns Hopkins
Baltimore, Maryland, 21231, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Scott BL, Pasquini MC, Logan BR, Wu J, Devine SM, Porter DL, Maziarz RT, Warlick ED, Fernandez HF, Alyea EP, Hamadani M, Bashey A, Giralt S, Geller NL, Leifer E, Le-Rademacher J, Mendizabal AM, Horowitz MM, Deeg HJ, Horwitz ME. Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol. 2017 Apr 10;35(11):1154-1161. doi: 10.1200/JCO.2016.70.7091. Epub 2017 Feb 13.
Ambinder RF, Wu J, Logan B, Durand CM, Shields R, Popat UR, Little RF, McMahon DK, Cyktor J, Mellors JW, Ayala E, Kaplan LD, Noy A, Jones RJ, Howard A, Forman SJ, Porter D, Arce-Lara C, Shaughnessy P, Sproat L, Hashmi SK, Mendizabal AM, Horowitz MM, Navarro WH, Alvarnas JC. Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies: The BMT CTN-0903/AMC-080 Trial. Biol Blood Marrow Transplant. 2019 Nov;25(11):2160-2166. doi: 10.1016/j.bbmt.2019.06.033. Epub 2019 Jul 4.
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
20 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2011
First Posted
August 5, 2011
Study Start
September 2011
Actual (reported)Primary Completion
Combination of Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL)
RIC Regimen (Flu/Mel): Fludarabine total dose: 120-180 mg/m\^2, Melphalan total dose: less than or equal to 150 mg/m\^2. Recommended regimen: * Days -5 to -2: Flu (30mg/m\^2/day, total dose of 120 mg/m\^2) * Day -1: Mel (140mg/m\^2) Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage.
MAC Regimen (Bu/Flu): Fludarabine total dose: 120-180mg/m\^2 Busulfan total dose less than or equal to 16mg/kg PO or 12.8 mg/kg IV. Recommended regimen: * Days -5 to -2: Busulfan (4 mg/kg/day PO with Bu Css 900 plus/equal to 100 ng/mL (or per institutional standard), 3.2 mg/kg/day IV or 130 mg/m\^2/day IV; total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m\^2, respectively) * Days -5 to -2: Flu (30 mg/m\^2/day, total dose of 120 mg/m\^2) Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage. Busulfan will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125 percent of IBW, in which case the drug will be dosed according to the adjusted IBW.
MAC Regimen (Cy/TBI): Cyclophosphamide total dose: 120 mg/kg, Fractionated TBI total dose: 1200-1420 cGy Recommended regimen: * Days -7 to -4: TBI (total dose of 1200-1420 cGy) * Days -3 to -2: Cy (60 mg/kg/day, total dose of 120 mg/kg) Cyclophosphamide will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs less than IBW, in which case the drug will be dosed according to the actual body weight.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Texas/MD Anderson CRC
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53211, United States
November 2016
Actual (reported)Study Completion
June 2018
Actual (reported)Last Updated
December 8, 2022
Results First Posted
May 24, 2018
Record last verified: 2022-12
Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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