Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
- Conditions
- Leukemia
- Interventions
- Biological: filgrastimProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00002768
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission.
- Detailed Description
OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral blood stem cell transplantation to generate a 2-year disease-free survival rate in at least 30% of patients with acute myeloid leukemia (AML) in second complete remission. II. Determine whether the treatment-related mortality can be limited to less than 20% in patients treated with this regimen. III. Determine whether adequate numbers of PBSC can be collected in these patients. IV. Determine the engraftment kinetics of primed PBSC obtained from these patients.
OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours and etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells. Conditioning: Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when blood counts recover, patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Patients with documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater before and/or after PBSC transplantation for a total of 6 doses. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Autologous stem cell transplantation filgrastim Patients receive consolidation chemotherapy followed by autologous stem cell transplantation Autologous stem cell transplantation peripheral blood stem cell transplantation Patients receive consolidation chemotherapy followed by autologous stem cell transplantation Autologous stem cell transplantation cytarabine Patients receive consolidation chemotherapy followed by autologous stem cell transplantation Autologous stem cell transplantation busulfan Patients receive consolidation chemotherapy followed by autologous stem cell transplantation Autologous stem cell transplantation methotrexate Patients receive consolidation chemotherapy followed by autologous stem cell transplantation Autologous stem cell transplantation etoposide Patients receive consolidation chemotherapy followed by autologous stem cell transplantation
- Primary Outcome Measures
Name Time Method Disease free survival 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States