TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA, A MULTICENTER TRIAL
filgrastim
+ asparaginase
+ cytarabine
Hematologic Diseases+8
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: January 1, 1993
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the toxic effects and feasibility of high-dose cytarabine and idarubicin in patients with refractory or relapsed acute lymphocytic leukemia (ALL) after a complete remission (CR) of less than 18 months. II. Determine the response of patients with ALL in first relapse after a CR of 18 months or more treated with a 2-phase re-induction regimen comprising prednisolone, vindesine, daunorubicin, asparaginase, intrathecal (IT) cytarabine, IT dexamethasone, and IT methotrexate followed by prednisolone, ifosfamide, high-dose methotrexate, leucovorin calcium, etoposide, and cytarabine (with a dose-escalation study of etoposide and cytarabine). III. Compare the effectiveness of these 2 regimens administered to these patients with the regimen administered to historic controls (protocol GER-ALL-REZ- 01/88). OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified by center, duration of complete remission (CR) (less than 18 months vs 18 months or more), and refractory disease (yes vs no). Patients with refractory or relapsed disease after a CR of less than 18 months are treated on Regimen A. Patients in first relapse after a CR of 18 months or more are treated on Regimen B. Regimen A: Patients receive idarubicin IV over 30 minutes followed by cytarabine IV over 3 hours on days 1-3 and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 5 and continuing until blood counts recover. Regimen B (2-phase reinduction): Patients receive oral prednisolone on days 1-21; vindesine IV and daunorubicin IV on days 1, 8, and 15; asparaginase IV on days 7, 8, 14, and 15; and methotrexate intrathecally (IT), cytarabine IT, and dexamethasone IT on days 1 and 8. When blood counts recover, patients receive oral prednisolone and ifosfamide IV over 1 hour on days 1-4; high-dose methotrexate IV continuously on day 1 followed by standard leucovorin calcium rescue; etoposide IV over 1 hour followed at least 8 hours later by cytarabine IV over 3 hours on days 3 and 4; and G-CSF SC beginning on day 6 and continuing until blood counts recover. Cohorts of 6 patients or more receive escalating doses of etoposide and cytarabine until the maximum tolerated dose is determined. PROJECTED ACCRUAL: Approximately 60 patients (30 per regimen) will be accrued for this study within 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 15 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Diagnosis of refractory or relapsed acute lymphocytic leukemia No isolated extramedullary relapse (e.g., testicular, CNS) Combined extramedullary and bone marrow relapse allowed No uncontrolled, severe leukemic complications, e.g.: Pneumonia with hypoxia Shock Cardiac failure Hemorrhage No refractoriness to platelet transfusion No unaspirable pleural effusions or ascites in patients with first relapse PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics No uncontrolled bleeding Hepatic: No severe liver disease Renal: Creatinine clearance at least 60 mL/min in patients with first relapse after a complete remission of 18 months or more Cardiovascular: See Disease Characteristics No severe cardiac disease (e.g., congestive heart failure, myocardial infarction within the past 6 months, or severe arrhythmia) Pulmonary: See Disease Characteristics No severe pulmonary disease that would preclude aggressive chemotherapy Other: No hypersensitivity to E. coli proteins No severe neurologic or other disease that would preclude aggressive chemotherapy No severe psychiatric disease or other condition that would preclude study PRIOR CONCURRENT THERAPY: Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Medizinische Hochschule Hannover
Hanover, GermanyOpen Medizinische Hochschule Hannover in Google Maps