Cyclophosphamide Plus T-Cell Transplantation for Patients With Hematologic Malignancies

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of abnormal blood cells, either by killing the cells or by stopping them from dividing. Giving cyclophosphamide together with donor lymphocytes that have been treated in the laboratory may be an effective treatment for myelodysplastic syndromes or myeloproliferative disorders.

PURPOSE: This clinical trial is studying the best dose of donor lymphocytes when given together with cyclophosphamide in treating patients with myelodysplastic syndromes or myeloproliferative disorders.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Myelodysplastic syndromes (MDS)

• International Prognostic Scoring System (IPSS) score ≥ intermediate-2

• Chronic myelomonocytic leukemia

• Acute myeloid leukemia arising from MDS

• Must have failed or are ineligible for or intolerant to treatment with azacitidine

• Patients with normal marrow cytogenetics or an isolated 5q- abnormality must have failed or are ineligible for or intolerant to treatment with lenalidomide

• Patients who are HLA-DR15-positive must have failed or are ineligible for pharmacologic immunosuppression (e.g., anti-thymocyte globulin, cyclosporine, steroids)

• No presence of cytotoxic antibodies against donor lymphocytes

• No HLA-identical donor available OR ineligible for HLA-identical allogeneic bone marrow transplantation

• HLA partially mismatched (haploidentical) related donor available

• First-degree related donor, including half-siblings or first cousins

• Inherited recombinant haplotype from parents allowed if donor shares ≥ 1 HLA antigen at each of the HLA-A, -B, and DR loci

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%

• Bilirubin < 3.0 mg/dL

• AST and ALT ≤ 4 times upper limit of normal

• Creatinine < 3.0 mg/dL

• LVEF > 35%

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• No prior transfusions from donor

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy

• No other concurrent investigational drugs