Leukemia Clinical Trial
Official title:
Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow
transplant helps stop the growth of cancer cells. It also helps stop the patient's immune
system from rejecting the donor's stem cells. When the stem cells from a related or
unrelated donor, that closely matches the patient's blood, are infused into the patient they
may help the patient's bone marrow to make stem cells, red blood cells, white blood cells,
and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in
treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
OBJECTIVES:
- Determine the survival of allogeneic bone marrow transplantation using closely matched
related and unrelated donors in patients with malignant or nonmalignant hematological
disorders.
- Determine the incidence and severity of acute and chronic graft versus host disease
with this treatment regimen in these patients.
- Determine the relapse rates with this treatment regimen in those patients with
malignant disorders.
- Determine the incidence and severity of infectious complications associated with this
treatment regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body
radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the
beginning of the study. If CNS involvement is documented, patients receive a second dose of
methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses.
Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week
for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant.
Patients with ALL receive total body radiotherapy for 5 consecutive days prior to
transplant.
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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