Acute Myeloid Leukemia Clinical Trial

Cyclophosphamide Plus T-Cell Transplantation for Patients With Hematologic Malignancies

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.

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Full Description

OBJECTIVES:

Determine the maximum tolerated dose of allogeneic CD8-positive T-cell-depleted, haploidentical donor lymphocytes when given after cyclophosphamide in patients with myelodysplastic syndromes or myeloproliferative disorders.

OUTLINE: Patients receive cyclophosphamide on days 1 and 2. Patients then undergo infusion of allogeneic T-cell depleted donor lymphocytes on day 3.

Cohorts of patients receive escalating doses of CD8-positive T-cell-depleted haploidentical donor lymphocytes until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT00356928

Recruitment Status:

Terminated

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

14

Study ID:

NCT00356928

Recruitment Status:

Terminated

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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