Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.

PURPOSE: This phase II trial is studying giving treosulfan together with fludarabine to see how well it works in treating patients who are undergoing a donor stem cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: medac GmbH; National Cancer Institute (NCI)
• Treatments: Busulfan; Fludarabine; Fludarabine phosphate; Treosulfan; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia, lymphoblastic leukemia, or myelodysplastic syndrome

• Any phase allowed, including any of the following:

• Disease in remission

• Relapsed or primary refractory disease

• No CNS leukemic involvement not clearing with prior intrathecal chemotherapy and/or cranial radiotherapy

• Planning to undergo unmanipulated allogeneic bone marrow or peripheral blood stem cell transplantation

• Filgrastim (G-CSF) mobilization of bone marrow or stem cells allowed

• Donor available, meeting 1 of the following criteria:

• HLA-identical related donor

• HLA-A, -B, -C, -DRB1, and -DQB1 matched unrelated donor by high-resolution DNA typing

• A single allele mismatch allowed

PATIENT CHARACTERISTICS:

Performance status

• Karnofsky 70-100% OR

• Lansky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• AST ≤ 2 times ULN

• No evidence of synthetic dysfunction

• No severe cirrhosis

• No active infectious hepatitis

Renal

• Creatinine clearance ≥ 50%

• Creatinine ≤ 2 times ULN

• Dialysis independent

Cardiovascular

• No cardiac insufficiency requiring treatment

• No symptomatic coronary artery disease

• Ejection fraction ≥ 35% (for patients with history of cardiac disease or anthracycline exposure)

Pulmonary

• PO_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR

• PO_2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted

• Not requiring supplementary continuous oxygen

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other disease that would severely limit life expectancy

• No HIV positivity

• No active infection requiring deferral of conditioning

• No known hypersensitivity to the study drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• No prior allogeneic bone marrow or stem cell transplantation

• No concurrent umbilical cord blood or autologous transplantation

Chemotherapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

Other

• More than 4 weeks since prior experimental drugs

• Concurrent enrollment on another protocol for graft-versus-host disease prophylaxis allowed