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Cyclophosphamide Plus Transplantation of Partially HLA-Mismatched (Haploidentical), CD8+ T Cell-Depleted Peripheral Blood Cells (PBCs) for Patients With Myelodysplastic (MDS) or Myeloproliferative Disorders (MPD)


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

Cyclophosphamide Plus Transplantation of Partially HLA-Mismatched (Haploidentical), CD8+ T Cell-Depleted Peripheral Blood Cells (PBCs) for Patients With Myelodysplastic (MDS) or Myeloproliferative Disorders (MPD)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of CD8-positive T-cell-depleted haploidentical donor lymphocytes

Safety Issue:

Yes

Principal Investigator

Yvette L. Kasamon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

J0551 CDR0000483771

NCT ID:

NCT00356928

Start Date:

May 2006

Completion Date:

May 2011

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • secondary acute myeloid leukemia
  • chronic myelomonocytic leukemia
  • de novo myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410