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Cyclophosphamide Plus Transplantation of Partially HLA-mismatched, CD8+ T Cell-depleted Peripheral Blood Cells for Patients With Myelodysplastic Syndrome , Refractory Acute Myeloid Leukemia, Refractory Lymphoma or Myeloproliferative Disorders

This study has been terminated.
(Poor accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00356928
First received: July 26, 2006
Last updated: January 25, 2012
Last verified: January 2012
History of Changes

July 26, 2006
January 25, 2012
May 2006
May 2011   (final data collection date for primary outcome measure)
Maximum tolerated dose of CD8-positive T-cell-depleted haploidentical donor lymphocytes [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00356928 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Cyclophosphamide Plus Transplantation of Partially HLA-mismatched, CD8+ T Cell-depleted Peripheral Blood Cells for Patients With Myelodysplastic Syndrome , Refractory Acute Myeloid Leukemia, Refractory Lymphoma or Myeloproliferative Disorders
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)

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.

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.
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Biological: donor lymphocytes
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: cyclophosphamide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00356928
J0551 CDR0000483771, R21CA121588, P30CA006973, JHOC-J0551, JHOC-NA_00000901
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP