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Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT00262795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2019-05-23

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles

DRUG

Chlorambucil

Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month

Sponsors & Collaborators

  • German CLL Study Group

    lead OTHER

Principal Investigators

  • Michael Hallek, MD · Medizinische Universitaetsklinik I at the University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2005-01-31
Completion
2005-10-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00262795 on ClinicalTrials.gov