TerminatedPhase 2

T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases

Stopped: slow accrual

United States13 participantsStarted 2004-01

Plain-language summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying T-cell depletion in donor stem cell transplant followed by delayed T cell infusions in treating patients with hematologic cancer or other disease.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of any of the following hematologic cancers or other diseases: * Acute myelogenous leukemia * Relapsed or refractory disease with poor-risk cytogenetics * Acute lymphoblastic leukemia * Relapsed or refractory disease with poor-risk cytogenetics * Chronic myelogenous leukemia * Persistent disease after at least 6 months of treatment with imatinib mesylate (Gleevec) * Myelodysplasia, meeting 1 of the following criteria: * French-American-British Classification of refractory anemia with excess blasts (RAEB) or RAEB with transformation * International Prognostic Scoring System score \> 2 * Lymphoid malignancies, including non-Hodgkin lymphoma, Hodgkin disease, chronic lymphocytic leukemia, and prolymphocytic leukemia * Relapsed or refractory disease after at least 1 prior therapy * Myelofibrosis * Transfusion dependent (RBC's, platelets, or both) * Paroxysmal nocturnal hemoglobinuria (transfusion dependent) * Myeloproliferative disorder * Eosinophilic leukemia * Severe aplastic anemia * Corrected reticulocyte count \< 1% * Platelet count \< 30,000/mm³ (untransfused) * Bone marrow biopsy with \< 15% cellularity * Plasma cell leukemia * No essential thrombocytopenia or polycythemia vera * No matched related donor available * Must have an 8/8 or 7/8 serologic HLA matched unrelated donor available PATIENT CHARACTERISTICS: * Cardiac ejection fraction ≥ 45% (if \< 45%, then car…

What they're measuring

Treatment-related Mortality (TRM)

Timeframe: 180 days after transplant

Trial details

NCT IDNCT00589602

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2016-09-20