Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive Ph+ Acute Leukemia - a Multi-Center Trial
PRIMARY OBJECTIVES:
I. To determine whether the rate of leukemia relapse can be decreased for patients with
chronic myelogenous leukemia in blast crisis (CML-BC) and philadelphia chromosome positive
acute lymphoblastic leukemia (Ph+ ALL) responsive to imatinib mesylate (or either dasatinib
or nilotinib for patients who have imatinib-resistant disease or who are intolerant of
imatinib) followed by nonmyeloablative hematopoietic stem cell transplantation (HSCT)
compared to historical controls given high-dose conventional allogeneic HSCT or
chemotherapy.
II. To determine whether the rate of transplantation-related mortality (TRM) can be
decreased for patients with CML-BC and Ph+ ALL responsive to imatinib mesylate (or dasatinib
or nilotinib) followed by nonmyeloablative HSCT compared to historical controls given
high-dose conventional allogeneic HSCT or chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate whether donor lymphocyte infusion (DLI) can be safely used in patients with
mixed or full donor chimerism as preemptive therapy to eliminate minimal residual disease.
OUTLINE:
INDUCTION THERAPY: Patients continue to receive imatinib mesylate orally (PO), dasatinib PO,
or nilotinib PO once or twice daily until day -2 and resume on day 14 or when blood counts
recover after peripheral blood stem cell (PBSC) transplantation.
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine intravenously (IV) on days -4 to
-2; and undergo TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSC transplantation on day 0.
GRAFT-VERSUS-HOST-DISEASE (GVHD) PROPHYLAXIS: Patients receive mycophenolate mofetil (MMF)
PO every 12 hours on days 0-27 (related donor recipients) or every 8 hours on days 0-96 with
taper on day 40 (unrelated donor recipients). Patients also receive cyclosporine IV or PO
every 12 hours on days -3 to 56, followed by taper on days 57-180 (related donor recipients)
or on days -3 to 100, followed by taper on days 101-177 (unrelated donor recipients).
DONOR LYMPHOCYTE INFUSION: Patients with persistent disease and no GVHD after stopping GVHD
prophylaxis receive donor lymphocyte infusion IV over 30 minutes once every 28 days for 3
doses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed up periodically for 2 years and then annually thereafter for 5 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of relapse
Assessed up to 5 years
No
George Georges
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
1581.00
NCT00036738
July 2001
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
VA Puget Sound Health Care System | Seattle, Washington 98101 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |