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Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: August 6, 2013
Last verified: March 2002

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory acute lymphocytic leukemia.

Condition Intervention Phase
Leukemia Biological: filgrastim Drug: asparaginase Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: idarubicin Drug: ifosfamide Drug: leucovorin calcium Drug: methotrexate Drug: prednisolone Drug: vindesine Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1993
Detailed Description:

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.


Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


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Please refer to this study by its identifier: NCT00002532

Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Sponsors and Collaborators
Hannover Medical School
Study Chair: Mathias Freund, MD Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
  More Information Identifier: NCT00002532     History of Changes
Other Study ID Numbers: GER-ALL-REZ-02/92
CDR0000078432 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: August 6, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal processed this record on August 18, 2017