Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

Phase 3

Completed

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

• Registration Number: NCT00262782
• Lead Sponsor: German CLL Study Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

Detailed Description

OBJECTIVES:

* Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.

OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk group are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive fludarabine.

* Arm II: Patients undergo observation only.

PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.

Study Timeline

• Study Start: 1997-04
• Primary Completion: 2004-12
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-07
• Study Completion: 2010-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 877

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fludarabine	Fludarabine	-

Trial Locations

Locations (115)

Hanuschkrankenhaus; 🇦🇹 Vienna, Austria

Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik; 🇦🇹 Wien, Austria

Klinikum St. Marien; 🇩🇪 Amberg, Germany

Internistische Praxis - Arnstadt; 🇩🇪 Arnstadt, Germany

Zentralklinikum Augsburg; 🇩🇪 Augsburg, Germany

Kreiskrankenhaus Aurich; 🇩🇪 Aurich, Germany

Regional Hospital Am Plattenwald; 🇩🇪 Bad Friedrichshall, Germany

Regional Hospital Bad Hersfeld; 🇩🇪 Bad Hersfeld, Germany

Arzt fuer Innere Medizin - Bad Reichenhall; 🇩🇪 Bad Reichenhall, Germany

Humaine - Clinic; 🇩🇪 Bad Saarow, Germany

Scroll for more (105 remaining)