Bethesda, Maryland 20892

  • Small Intestine Cance

Purpose:

RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy 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 T cells from the donor cells before transplant and giving cyclosporine or tacrolimus before and after transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer or abnormal cells as not belonging to the patient's body and destroy them (graft-versus-tumor effect). PURPOSE: This phase II trial is studying how well a donor peripheral blood stem cell transplant works in treating patients with hematologic cancer or other disease.


Study summary:

OBJECTIVES: - Determine the overall survival rate at day 200 in patients with hematologic cancers or other diseases who undergo allogeneic peripheral blood stem cell transplantation using the CliniMACS® CD34 Reagent System for T-cell depletion followed by delayed T-cell add-back. - Determine the safety of this regimen, in terms of the nonrelapse mortality rate at day 200, in these patients. OUTLINE: - Myeloablative preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients also undergo high-dose* total body irradiation (TBI) twice daily on days -7 to -4. NOTE: *Patients over 55 years of age receive reduced-dose TBI. - Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients receive T-cell-depleted (via the CliniMACS® CD34 Reagent System), filgrastim (G-CSF)-mobilized, donor PBSC IV over 4 hours on day 0. - Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine (or tacrolimus) IV or orally twice daily on days -6 to 21, and then again beginning on day 89 and continuing up to day 150, followed by a slow taper to day 180, in the absence of GVHD. - Donor lymphocyte infusion (DLI): Patients receive delayed T-cell add-backs of donor lymphocytes IV over 1 hour on day 90. If relapse occurs, patients may receive DLI before day 90 or as a repeat infusion. After completion of study therapy, patients are followed periodically for 3 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Chronic myelogenous leukemia (CML), meeting 1 of the following criteria: - Under 21 years of age and in chronic phase - Ten to 75 years of age with CML in chronic phase, meeting 1 of the following criteria: - Failed or intolerant to prior treatment with imatinib mesylate - No prior therapeutic doses of imatinib mesylate within 12 months after disease diagnosis - Ten to 75 years of age with CML in accelerated phase or blast transformation - Acute lymphoblastic leukemia, meeting 1 of the following criteria: - In first remission with any of the following high-risk features: - WBC > 100,000/mm³ at diagnosis - Karyotypes t9; 22, t4, t19, t11, or biphenotypic leukemia - In second or subsequent remission - Primary induction failure - Partially responding or untreated relapsed disease - Acute myeloid leukemia (AML), meeting 1 of the following criteria: - In first remission - No AML with good-risk karyotypes (e.g., M3 [t15; 17], M4Eo [inv 16], t [8; 21]) - In second or subsequent remission - Primary induction failure - Resistant relapsed disease - Myelodysplastic syndromes (MDS), including any of the following subtypes: - Refractory anemia with transfusion dependence - Refractory anemia with excess blasts - MDS in transformation to acute leukemia - Chronic myelomonocytic leukemia - Atypical MDS/myeloproliferative disorders - Myeloproliferative disorders, including any of the following subtypes: - Atypical (Philadelphia chromosome negative) chronic myelogenous or neutrophilic leukemias - Progressing myelofibrosis - Polycythemia vera - Essential thrombocythemia in transformation to acute leukemia - Essential thrombocythemia with progressive transfusion requirements or pancytopenia - Chronic lymphocytic leukemia - Refractory to fludarabine phosphate treatment AND meets 1 of the following criteria: - Bulky progressive disease - Thrombocytopenia (i.e., platelet count ≤ 100,000/mm^3) not due to recent chemotherapy - Anemia (i.e., hemoglobin ≤ 10 g/dL) not due to recent chemotherapy - Non-Hodgkin's lymphoma, including mantle cell lymphoma, that has relapsed or is refractory to standard-of-care treatments - Multiple myeloma or Waldenstrom's macroglobulinemia that is unresponsive to or relapsed after standard-of-care treatments - HLA-identical (6/6) related donor available PATIENT CHARACTERISTICS: - Life expectancy ≥ 3 months - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No major anticipated illness or organ failure incompatible with survival from transplantation - No severe psychiatric illness or mental deficiency that would preclude study compliance - HIV negative - DLCO ≥ 65% of predicted - LVEF ≥ 40% - AST ≤ 20 times upper limit of normal (ULN) - Bilirubin ≤ 10 times ULN - Creatinine ≤ 6 times ULN PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior allogeneic stem cell transplantation


NCT ID:

NCT00398346


Primary Contact:

Study Chair
Aarthi Shenoy, MD
National Heart, Lung, and Blood Institute (NHLBI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - NIH - Warren Grant Magnuson Clinical
Phone: 800-411-1222

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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