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TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA, A MULTICENTER TRIAL


Phase 2
15 Years
65 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mathias Freund, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

Authority:

United States: Federal Government

Study ID:

CDR0000078432

NCT ID:

NCT00002532

Start Date:

January 1993

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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