Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Acute Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or acute leukemia.
Biological: recombinant interferon alfa
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Pilot Study of Intensive Chemotherapy Followed by Peripheral Blood Stem Cell Harvesting for Autotransplantation of Adults With Chronic Myelogenous Leukemia and High Risk Acute Leukemia|
|Study Start Date:||October 1999|
|Study Completion Date:||September 2004|
OBJECTIVES: I. Determine safety and toxicity of induction and transplant regimens in patients with chronic myelogenous leukemia or high-risk acute leukemia. II. Determine efficacy of collecting peripheral blood stem cells (PBSC) during early hematopoietic recovery from intensive chemotherapy as a means for in vivo enrichment for cytogenetically normal progenitor cells in this patient population. III. Correlate cytogenetic and molecular responses in the peripheral blood and bone marrow with clinical response, time to progression, and survival in these patients at several timepoints before and after myelosuppressive and myeloablative therapy.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (chronic myelogenous leukemia vs acute lymphoblastic leukemia vs acute myelogenous leukemia). Patients receive cytarabine IV over 4 hours, etoposide IV over 1.5-2 hours, and idarubicin IV over 5-10 minutes on days 1, 3, and 5. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on day 2 and continuing until blood counts recover. Chronic myelogenous leukemia: On day 14 following chemotherapy, if bone marrow biopsy shows less than 20% cellularity and a peripheral blood sample contains greater than 50% cytogenetically normal cells, patients receive a second induction course followed by apheresis. Patients with less than 50% cytogenetically normal cells are also considered for a second induction course. Patients with no response or progressive disease are removed from the study. Acute leukemia: On day 14 following chemotherapy, if bone marrow biopsy shows less than 20% cellularity and the peripheral blood sample shows 100% cytogenetically normal cells, patients receive a second induction course followed by apheresis. Patients with high risk disease in first remission at time of study entry undergo apheresis during recovery from first course of induction therapy and second course may be omitted. Patients receive second induction course followed by G-CSF as after first induction course. Once blood counts recover, patients undergo harvest of peripheral blood stem cells (PBSC). Patients also undergo bone marrow stem cell collection in case of failure of PBSC transplantation (PBSCT). Patients receive the following conditioning regimen: total body irradiation twice a day on days -8 to -5; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 2 hours on day -2. PBSCT is conducted on day 0. G-CSF SC is administered beginning on day 1 and continues until blood counts recover. Patients receive maintenance therapy with interferon alfa SC 3 times a week for 12 months. Patients are followed weekly for 3 months and then monthly until death.
PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004905
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Study Chair:||Jane N. Winter, MD||Robert H. Lurie Cancer Center|