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

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ClinicalTrials.gov Identifier: NCT00002532
Recruitment Status : Unknown
Verified March 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 16, 2004
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE February 16, 2004
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE January 1993
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002532 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
Official Title  ICMJE TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA, A MULTICENTER TRIAL
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002532
Other Study ID Numbers  ICMJE GER-ALL-REZ-02/92
CDR0000078432 ( Registry Identifier: PDQ (Physician Data Query) )
EU-93001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hannover Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mathias Freund, MD Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
PRS Account National Cancer Institute (NCI)
Verification Date March 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP