Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy drugs before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or myeloproliferative disorder.

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA)

• RA with excess blasts (RAEB) (greater than 5% blasts)

• RAEB in transformation (greater than 20% but less than 30% blasts)

• Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS

• Myeloproliferative disorder, including chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis

• No chronic myelogenous leukemia with or without excess (greater than 5%) blasts

• Must have an HLA-identical, related donor

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Performance status

• Not specified

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)*

• SGOT/SGPT less than 2 times ULN* NOTE: * Unless due to malignancy

Renal

• Creatinine no greater than 2.0 mg/dL OR

• Glomerular filtration rate at least 60 mL/min

Cardiovascular

• Cardiac ejection fraction at least 45%

Pulmonary

• DLCO at least 60% of predicted

Other

• HIV negative

• Human antimouse antibody negative

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other medical condition that would preclude study participation

• No hypersensitivity to cyclosporine

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior marrow transplantation

• No concurrent growth factors for 21 days after study transplantation

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified