Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening. Infusions of donor lymphocytes may decrease the body's rejection of the transplanted peripheral stem cells. PURPOSE: Phase II trial to study the effectiveness of allogeneic stem cell transplantation followed by donor lymphocyte infusions in treating patients who have hematologic cancer.


Study summary:

OBJECTIVES: - Determine the effect of irradiated donor T-cell infusion on donor T-cell chimerism 6 weeks after hematopoietic stem cell transplantation in patients with hematologic malignancies. - Determine the infusional toxic effects of irradiated donor lymphocytes in these patients. - Determine the risk of acute and chronic graft-versus-host disease from donor lymphocyte infusions on day 45 and day 100 posttransplantation in HLA 6/6 matched transplantations from a related donor in these patients. - Determine disease-free survival, cytomegalovirus reactivation, and relapse in patients treated with this regimen. - Determine transplant-related mortality and death from all causes in patients treated with this regimen. OUTLINE: - Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo total body irradiation on days -7 to -4. - Pretransplantation irradiated donor lymphocyte infusion (DLI): Patients receive irradiated DLI on day -4. - Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0. - Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days 44-120. - Posttransplantation DLI: Patients receive DLI on days 45 and 100. Patients with chronic myelogenous leukemia in chronic phase who are polymerase chain reaction negative for bcr/abl receive DLI on day 45 only. Patients are followed at 3, 6, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of any of the following hematologic malignancies: - Chronic myelogenous leukemia (CML) in chronic phase meeting 1 of the following criteria: - Under 41 years of age with no prior imatinib mesylate therapy - 10 to 55 years of age and failed prior imatinib mesylate therapy - 41 to 55 years of age for whom imatinib mesylate is not the treatment of choice - CML in accelerated phase or blast transformation - Acute lymphoblastic leukemia meeting any of the following criteria: - Over 18 years of age and in first remission with high-risk features (e.g., WBC greater than 100,000/mm^3, karyotypes t[9;22], t[4], t[19], t[11], and biphenotypic leukemia) - Second or subsequent remission - Primary induction failure - Partially responding or untreated relapse - Acute myeloid leukemia meeting any of the following criteria: - First remission, except with good-risk karyotypes (e.g., M3 t[15;17], M4E0 inv[16], t[8;21]) - Second or subsequent remission - Primary induction failure - Resistant relapse - Myelodysplastic syndromes of any of the following types: - Refractory anemia (RA) with transfusion dependence - RA with excess blasts - In transformation to acute leukemia - Chronic myelomonocytic leukemia - Myeloproliferative disorders in transformation to acute leukemia, of any of the following types: - Myelofibrosis - Polycythemia vera - Essential thrombocythemia - Chronic lymphocytic leukemia that is refractory to fludarabine with 1 of the following: - Bulky progressive disease - Thrombocytopenia (WBC no greater than 100,000/mm^3)* - Anemia (hemoglobin no greater than 10 g/dL)* NOTE: *Not due to recent chemotherapy - Non-Hodgkin's lymphoma, including mantle cell lymphoma, relapsing or refractory to current chemotherapy and monoclonal antibody therapy and unsuitable for autologous stem cell transplantation - Availability of a HLA-identical (6/6) family donor PATIENT CHARACTERISTICS: Age - 10 to 55 Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 4 mg/dL - Transaminases no greater than 3 times upper limit of normal Renal - Creatinine no greater than 3 mg/dL Cardiovascular - LVEF at least 40% of predicted Pulmonary - DLCO at least 60% of predicted Other - Not pregnant - Negative pregnancy test - HIV negative - No severe psychiatric illness or mental deficiency that would preclude giving informed consent or complying with study treatment - No major illness or organ dysfunction that would preclude transplantation - No other prior malignancy except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics - No prior continuous busulfan for more than 6 months duration Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00066300


Primary Contact:

Study Chair
Austin J. Barrett, MD, FRCP
NHLBI - Bone Marrow Transplantation Unit


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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