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Phase II Study of Donor Leukocyte Infusions in Patients with Recurrent or Persistent Hematologic Malignancies After Allogeneic Bone Marrow Transplantation (Summary Last Modified 01/2000)
Alternate Title White Blood Cells in Treating Patients With Recurrent or Persistent Hematologic Cancers
Objectives I. Assess the response rates and graft versus host disease using donor leukocyte infusions (DLI) in patients with relapsed or persistent acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndrome, multiple myeloma, non-Hodgkin's lymphoma, or Hodgkin's disease. II. Assess response rates in the patients with minimal disease either because of molecular- or cytogenetic-only relapse or because DLI given in nadir-period postchemotherapy. III. Assess response rates and graft versus host disease in patients given lower cell doses (either early relapse of chronic myelogenous leukemia or mismatched family or unrelated donors). IV. Assess the efficacy of concurrent donor hematopoietic stem cells infused with DLI in abrogating pancytopenia in patients with low percentage donor chimerism at the time of treatment. V. Assess the predictive value of various recipient malignant cell phenotypic features in predicting response in these patients. Entry Criteria Disease Characteristics: Histologically confirmed relapsed or persistent hematologic malignancy Chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS), multiple myeloma (MM), non-Hodgkin's lymphoma (NHL), or Hodgkin's disease (HD) CML - Molecular relapse (molecular relapse is not treated if the donor was an unrelated donor) Bone marrow transplantation (BMT) was T cell depleted and bcr/abl detectable by 2 consecutive PCR determinations greater than 30 days apart at any time after day 100 postallogeneic stem cell transplant BMT was non-T cell depleted, a negative bcr/abl by PCR has been documented postallogeneic stem cell transplant and bcr/abl is now detectable by 2 consecutive PCR determinations greater than 30 days apart BMT was non-T cell depleted and bcr/abl is detectable by PCR determination at any time after day 180 postallogeneic stem cell transplant OR - Cytogenetic relapse OR - Relapse with chronic phase, accelerated phase, or blastic phase disease AML, ALL, or MDS - Molecular relapse (less than 5% blasts) Leukemia-specific molecular abnormality is detectable by PCR analysis, provided a previous posttransplant PCR analysis has been negative OR - Cytogenetic relapse (less than 5% blasts) Leukemia-specific chromosome abnormality detectable by standard cytogenetics at any time greater than day 50 posttransplant OR - Hematologic relapse MM - Relapse Recurrence of M-protein after previous posttransplant documentation of disappearance of M-protein by immunofixation OR - Residual disease Rising M-protein level at any time posttransplant M-protein detectable at 6 months posttransplant OR - IEP is required to show that M-component is the same as pretransplant NHL or HD - Relapse Clearcut growth of disease by serial physical exam, radiographic studies, or molecular studies is required to define relapse No active acute or chronic graft versus host disease Original bone marrow donor available for lymphocyte donation Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Prior steroids must be tapered off over 1-4 weeks as clinically indicated No concurrent steroids Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since any prior immunosuppressive therapy Patient Characteristics: Age: 65 and under Performance status: Not specified Life expectancy: At least 4 weeks Hematopoietic: Platelet count at least 20,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.5 mg/dL Other: HIV negative Not pregnant or nursing Expected Enrollment There will be 210-530 patients accrued into this study over 3 years. Outline This is a multicenter study. Patients receive donor leukocyte infusion (DLI) over 30-60 minutes without pre-DLI chemotherapy, 10-14 days after beginning of chemotherapy, or after recovery from chemotherapy. Patients with chronic myelogenous leukemia (CML) at accelerated phase or blast phase receive either cytarabine/daunorubicin, vincristine/prednisone/daunorubicin, or another chemotherapy regimen at the physician's discretion prior to DLI. Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) at hematologic relapse receive cytarabine/daunorubicin or another chemotherapy regimen at the physician's discretion prior to DLI. Patients with acute lymphocytic leukemia (ALL) at hematologic relapse receive vincristine/prednisone/daunorubicin or another chemotherapy regimen at the physician's discretion prior to DLI. Patients with non-Hodgkin's lymphoma (NHL) receive cyclophosphamide/doxorubicin/prednisone/vincristine, and patients with Hodgkin's disease (HD) receive bleomycin/dacarbazine/doxorubicin/vinblastine or another chemotherapy regimen at the physician's discretion prior to DLI. Patients with persistent disease after the initial DLI (16 weeks from CML in molecular, cytogenic, or chronic phase relapse, 12 weeks for multiple myeloma, 4 weeks for AML, ALL, MDS, NHL, HD who have not developed graft versus host disease or disease response after the initial DLI) are eligible for a second DLI. Patients are followed monthly for 3 months, then every 3 months for 9 months, then every 6 months for 2 years, and then annually thereafter. Trial Lead Organizations Roswell Park Cancer Institute
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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