Status:
TERMINATED
Cyclophosphamide Plus T-Cell Transplantation for Patients With Hematologic Malignancies
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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. Givin...
Detailed 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 synd...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00356928
Start Date
October 1 2006
End Date
May 1 2011
Last Update
August 20 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410