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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 is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356928
First Posted: July 27, 2006
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose

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.


Condition Intervention
Leukemia Myelodysplastic Syndromes Biological: donor lymphocytes Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose of CD8-positive T-cell-depleted haploidentical donor lymphocytes

Enrollment: 9
Study Start Date: May 2006
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356928


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00356928     History of Changes
Other Study ID Numbers: J0551 CDR0000483771
R21CA121588 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0551
JHOC-NA_00000901
First Submitted: July 26, 2006
First Posted: July 27, 2006
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
secondary acute myeloid leukemia
chronic myelomonocytic leukemia
de novo myelodysplastic syndromes

Additional relevant MeSH terms:
Syndrome
Leukemia
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists