A Pilot Study of Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Chronic Myeloid Leukemia (CML) and Adoptive Cellular Immunotherapy Only in Patients With Persistent Disease and Matched Family Donors
Further study details will be provided by Columbia University, Division of Pediatric Blood
and Marrow Transplantation.
Patients less than 30 years of age with CML in 1st or 2nd chronic phase or 1st accelerated
phase and a matched related donor, an unrelated cord blood donor, or an unrelated adult
donor, will receive 6 days of IV Fludarabine, 4 doses of IV Busulfex, and 5 doses of
Alemtuzumab. Patients with persistant RT-PCR positive BCR-Abl and/or Philadelphia chromosome
positivity by cytogentics after Day + 100 and a matched related donor would receive DLIx1.
If still BCR-Abl or Philadelphia chromosome positive at Day +180 and a matched related
donor, patients would receive a second dose of DLI. All patients will receive STI-571
(Gleevec) after hematological reconstitution. Studies for immune reconstitution, chimersim,
and MRD will be performed postt AlloSCT.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the toxicity associated with reduced intensity therapy and allogeneic SCT in selected patients with CML.
Until Study End
Mtchell S Cairo, MD
United States: Institutional Review Board
|Morgan Stanley Children's Hospital of NYP||New York, New York 10032|