Leukemia Clinical Trial
Official title:
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Sibling Donors For Treatment Of Patients With High Risk Acute Lymphocytic Leukemia In Complete Remission
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Peripheral stem cell transplantation may be able to replace
immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the
transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and
donor white blood cells may prevent this from happening.
PURPOSE: Phase I/II trial to determine the effectiveness of combination chemotherapy and
total-body irradiation followed by peripheral stem cell transplantation in treating patients
who have acute lymphoblastic leukemia.
OBJECTIVES:
- Determine if a one-year disease free survival of 40% and a day 200 transplant-related
mortality of less than 25% can be achieved in patients with high-risk acute
lymphoblastic leukemia in complete remission treated with a nonmyeloablative
conditioning regimen comprising fludarabine and total body irradiation followed by
allogeneic peripheral blood stem cell or bone marrow transplantation.
- Evaluate the efficacy and toxicity of donor lymphocyte infusion in the treatment of
minimal residual disease after nonmyeloablative allografting in these patients.
OUTLINE: This is a multicenter study.
Patients receive a nonmyeloablative conditioning regimen comprising fludarabine IV on days
-4 to -2 and total body irradiation (TBI) on day 0. Children undergo allogeneic peripheral
blood stem cell transplantation (PBSCT) or bone marrow transplantation after TBI on day 0.
Adults undergo filgrastim (G-CSF)-mobilized allogeneic PBSCT after TBI on day 0.
Patients also receive graft-versus-host disease (GVHD) prophylaxis therapy comprising oral
cyclosporine twice daily on days -3 to 56 and then tapered and oral mycophenolate mofetil
once at 5-10 hours after transplantation on day 0 and then twice daily on days 1-27.
Patients who have no evidence of grade 2 or greater acute GVHD or clinically extensive
chronic GVHD, have been off GVHD prophylaxis therapy for 1-2 weeks, and have stable or
increasing minimal residual disease after discontinuation of GVHD prophylaxis therapy
receive donor lymphocyte infusion (DLI) IV over 30 minutes. DLI repeats every 4 weeks for a
total of 3 doses (if necessary).
Patients without a history of CNS leukemia and patients with a history of CNS leukemia
previously treated with prophylactic craniospinal irradiation receive methotrexate (MTX) or
cytarabine (ARA-C) intrathecally (IT) for a total of 2 doses before transplantation and for
a total of 6 doses beginning on day 32 after transplantation. Patients with a history of CNS
leukemia not previously treated with craniospinal irradiation undergo craniospinal
irradiation for 11 days before conditioning regimen and then MTX or ARA-C IT for a total of
6 doses beginning on day 32 after transplantation. Male patients also undergo testicular
radiotherapy for 7 days.
Patients are followed at 1, 2, 3, 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 30 patients (20 adults and 10 children) will be accrued for
this study within 2 years.
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Masking: Open Label, Primary Purpose: Treatment
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