Overview

Bone Marrow Transplantation in Treating Patients With Leukemia

Status:
Withdrawn
Trial end date:
2000-11-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Treatments:
Antilymphocyte Serum
Cyclophosphamide
Cyclosporine
Cyclosporins
Methotrexate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS: Acute myelocytic leukemia with or without history of
myelodysplastic syndrome Not in first complete remission (i.e., greater than 5% blasts in
marrow) with t(8;21), t(15;17), or 16q abnormality unless failure on first-line induction
therapy Acute lymphocytic leukemia (ALL) in one of the following categories: In second or
third complete remission (CR) High-risk ALL in first CR, with high risk defined as:
Hypodiploidy OR pseudodiploidy with t(9;22), t(4;11), or t(8;14) Failure to achieve CR
after 4 weeks of induction therapy Elevated WBC at presentation, i.e.: Greater than 100,000
in patients aged 6 to 12 months Greater than 200,000 in patients aged 1 to 20 years Greater
than 20,000 in patients aged 21 to 44 years Chronic myelogenous leukemia not in blast
crisis (i.e., no greater than 30% promyelocytes plus blasts in bone marrow) Stage IV
lymphoblastic lymphoma Undifferentiated or biphenotypic leukemia Unrelated donor available
Patients aged 35 and younger: HLA-A, and -B serologic identity and HLA-DRB1 identity by
high-resolution DNA typing OR Single HLA-A or -B serologic mismatch with DRB1 identity by
high-resolution DNA typing OR HLA-A and -B serologic identity with single DRB1 mismatch by
high- or low- resolution DNA typing Patients aged 36 to 44: HLA-A and -B serologic identity
and HLA-DRB1 identity by high-resolution DNA typing The following exclude: Relapse 12
months after discontinuing therapy in patients aged 1 to 10 years who are in second
remission Active central nervous system or leukemic skin involvement Requirement for
additional mediastinal irradiation

PATIENT CHARACTERISTICS: Age: Under 46 Performance status: Karnofsky 70-100% Lansky 50-100%
Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 mg/dL AST less
than 3 times normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min
Cardiovascular: Asymptomatic OR Resting LVEF greater than 40% and improves with exercise
Pulmonary: Asymptomatic OR DLCO greater than 45% of predicted (corrected for hemoglobin)
Other: HIV negative No uncontrolled viral, bacterial, or fungal infection Not pregnant or
nursing

PRIOR CONCURRENT THERAPY: No prior bone marrow transplantation No prior radiotherapy that
precludes total body irradiation