Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Disease or Hematologic Cancer

This study is currently recruiting patients.

Sponsored by

National Cancer Institute (NCI)

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte globulin may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have hematologic disease or hematologic cancer.

Study Type: Treatment

Official Title: Phase II Study of Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation in Patients with Hematologic Disease or Cancer

Further Study Details: OBJECTIVES: I. Determine the safety and toxicity of a low intensity nonmyeloablative preparative regimen followed by an allogeneic peripheral blood stem cell transplant in high risk patients with hematologic cancer or disease. II. Determine engraftment in these patients. III. Determine the incidence and severity of acute and chronic graft versus host disease following the transplant in these patients. IV. Determine the efficacy of controlling hematologic cancers by induction of a graft versus tumor effect. V. Determine the rate of disease free survival, relapse, transplant related mortality, and death from all causes in these patients.  PROTOCOL OUTLINE: Patients are stratified by risk of graft rejection, which determines the preparative regimen used. High risk is defined as patients with aplastic anemia, those heavily transfused, chemotherapy naive, and single HLA locus mismatched. Patients undergo leukapheresis prior to beginning the preparative regimen. Patients then receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1. High risk patients also receive antithymocyte globulin IV on days -5 to -2. Patients undergo peripheral blood stem cell transplantation on day 0. Cyclosporine is administered from day -4 to day 100. Patients with disease progression or donor T-cell chimerism less than 100% after day 100 receive donor lymphocyte infusions up to every 4 weeks until 100% donor T-cell chimerism and/or disease regression is achieved. Patients are followed at 3 and 6 months, then every 6 months for 2.5 years, then annually for 2 years.  PROJECTED ACCRUAL: A total of 45 patients will be accrued for each group, for a total of 90 patients in this study.  

Eligibility

Ages Eligible for Study:  10 Years    -   80 Years Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Group A: Any of the following diseases: Chronic myelogenous leukemia in chronic phase Acute lymphoblastic leukemia in complete or partial remission Acute myelogenous leukemia (AML) in first complete or partial remission except for AML with good risk karyotypes: AML M3 t(15;17), AML M4Eo (inv. 16), AML t(8;21) AML in second or subsequent complete remission Myelodysplastic syndromes Refractory anemia with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Myeloproliferative diseases associated with either cytopenia or uncontrolled proliferation Chronic lymphocytic leukemia in complete or partial remission Prolymphocytic leukemia in complete or partial remission Mantle cell lymphoma Lymphoproliferative disorders Viral associated hemophagocytic syndromes Relapsed Hodgkin's disease Relapsed non-Hodgkin's lymphoma Therapy responsive or stable plateau phase multiple myeloma or extramedullary plasmacytomas AND Age 10 to 55 with high risk for transplant related complications and mortality due to history of one of the following: Dose intensive chemotherapy or radiotherapy History of allogeneic or autologous transplant History of multiple myeloma or extramedullary plasmacytoma Chronic disease or comorbid medical condition including significant pulmonary, hepatic, kidney, cardiac, or other organ system disease that would result in increased risk of death from a standard myeloablative transplant Group B: Any of the following diseases: Paroxysmal nocturnal hemoglobinuria associated with life threatening thrombosis, cytopenia, transfusion dependence, or recurrent debilitating hemolytic crisis (age 10 to 80) Aplastic anemia associated with transfusion dependence and/or neutropenia and failed immunosuppressive therapy (age 45 to 80) Refractory anemia (RA) or RA with ringed sideroblasts that has failed treatment with antithymocyte globulin or cyclosporine, with transfusion dependence and/or neutropenia (age 10 to 80) AND Curable by allogeneic bone marrow transplant but high procedural mortality with conventional bone marrow transplant may delay or prevent this treatment --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Age: 10 to 80 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Bilirubin no greater than 4 mg/dL SGOT/SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: LVEF at least 30% Pulmonary: DLCO at least 40% predicted Other: Not pregnant or nursing No psychiatric disorder or severe mental deficiency No other major illness or organ failure No other malignant disease liable to relapse or progress within 5 years

Location and Contact Information

Maryland

National Heart, Lung, and Blood Institute, Bethesda,   Maryland,   20892,   United States; Recruiting

Richard W. Childs       301-496-5093   

Study chairs or principal investigators

Richard W. Childs,  Study Chair

National Heart, Lung, and Blood Institute (NHLBI)   

More Information

Study ID Numbers  199/14184;   NHLBI-99-H-0050

NLM Identifier  NCT00003838

Date study started May 1, 1999

Last Updated  September 1, 1999

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