CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

November 30, 2017

Study Completion Date

August 31, 2018

Conditions
LeukemiaLymphomaBone Marrow FailureImmunodeficienciesHistiocytosisSickle Cell DiseaseBeta ThalassemiaInborn Errors of Metabolism
Interventions
DRUG

Full Intensity with TBI

Patients will start their pre-conditioning regimen on Day -8. Fractionated TBI will be administered twice daily for 3 days on Days -8, -7, and -6. Patients will receive Thiotepa on Days -5, -4, Cyclophosphamide on Days -3, -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1. The stem cell infusion will be performed on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus only.

DRUG

Full Intensity

Patients will start their pre-conditioning regimen on Day -9. Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with stem cell infusion on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus only.

DRUG

Reduced Intensity

Patients will start their GVHD prophylaxis with Tacrolimus on Day -9. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The stem cell infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus only.

DRUG

Reduced Intensity (Fanconi)

Patients will start their pre-conditioning regimen on Day -6. Patients will receive TBI as a single fraction on Day -6. Patients will receive fludarabine and cyclophosphamide on Days - 5, -4, -3, and -2 and antithymocyte globulin (horse) on Days -5, -4, -3, -2 and -1. The stem cell infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus only.

Trial Locations (1)

10595

New York Medical College, Valhalla

Sponsors
All Listed Sponsors
lead

New York Medical College

OTHER