Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Combining antithymocyte globulin with combination chemotherapy before donor peripheral stem cell transplantation may reduce the chance of developing graft-versus-host disease following transplantation.

PURPOSE: Phase I/II trial to study the effectiveness of combining antithymocyte globulin with busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for myelodysplastic syndrome or other 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: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Myelodysplastic syndromes (including those that have evolved to acute myeloid leukemia)

• Myeloproliferative disorders

• No chronic myelogenous leukemia

• Other diseases eligible for conditioning with targeted busulfan, cyclophosphamide, and anti-thymocyte globulin that are not candidates for other studies

• Available related or unrelated donor compatible for HLA-A, -B, -C, DRB1, and DQB1

• A single allele mismatch at HLA-A, -B, -C, or DRB1 is allowed

PATIENT CHARACTERISTICS:

Age

• 65 and under

Performance status

• Not specified

Life expectancy

• No severe limitation due to other diseases

Hematopoietic

• Not specified

Hepatic

• AST no greater than 2 times normal

• No hepatic disease

Renal

• Creatinine no greater than 2 times upper limit of normal OR

• Creatinine clearance at least 50% for age, gender, and weight

Cardiovascular

• No cardiac insufficiency requiring treatment

• No symptomatic coronary artery disease

Pulmonary

• No severe or mild hypoxemia

• pO_2 at least 70 mm Hg and DLCO at least 70% of predicted OR

• pO_2 at least 80 mm Hg and DLCO at least 60% of predicted

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No growth factors given posttransplantation concurrently with methotrexate immunosuppression

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified