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

Phase 3

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Chlorambucil; Drug: Fludarabine

• Registration Number: NCT00262795
• Lead Sponsor: German CLL Study Group

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.

* Compare the duration of remission in patients treated with these regimens.

Secondary

* Compare the incidence of toxicity, especially infections, in patients treated with these regimens.

* Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses.

* Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months.

PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-01
• Study Completion: 2005-10
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLB	Chlorambucil	Chlorambucil
F	Fludarabine	Fludarabine

Trial Locations

Locations (88)

Hanuschkrankenhaus; 🇦🇹 Vienna, Austria

Klinikum St. Marien; 🇩🇪 Amberg, Germany

Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie; 🇩🇪 Ansbach, Germany

Zentralklinikum Augsburg; 🇩🇪 Augsburg, Germany

Humaine - Clinic; 🇩🇪 Bad Saarow, Germany

Krankenhaus Hohe Warte Mediziniche Klinik; 🇩🇪 Bayreuth, Germany

Onkologisches Versorgungszentrum Friedrichshain; 🇩🇪 Berlin, Germany

Internistische Gemeinschaftspraxis - Berlin; 🇩🇪 Berlin, Germany

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Charite - Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

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