TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA, A MULTICENTER TRIAL
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.
Primary Purpose: Treatment
Mathias Freund, MD
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
United States: Federal Government