Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia

Phase 3

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Fludarabine plus Cyclophosphamide; Drug: Fludarabine

• Registration Number: NCT00276848
• Lead Sponsor: German CLL Study Group

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, 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 giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.

Detailed Description

OBJECTIVES:

Primary

* Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide.

Secondary

* Compare the incidence of side effects and quality of life of patients treated with these drugs.

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

* Arm I: Patients receive fludarabine IV on days 1-5.

* Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Study Timeline

• Study Start: 1999-07
• Primary Completion: 2003-07
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Study Completion: 2007-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fludarabine plus Cyclophosphamide	Fludarabine plus Cyclophosphamide	-
Fludarabine	Fludarabine	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	18 Month after end of treatment of the last patient	date of randomization until progression of disease or death of any cause
Overall survival	18 Month after end of treatment of the last patient	Date of randomization until date of death
Duration of remission	18 Month after end of treatment of the last patient	Clinical response was defined according to the guidelines of the NCI-sponsored workshop

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects	up to 28 days after the last dose of study medication	Toxic effects of treatment were evaluated according to the Common Toxicity Criteria (CTC 1.0)
Quality of life	18 Month after end of treatment of the last patient	EORTC QUOL Questionnaire

Trial Locations

Locations (133)

Allgemeines Krankenhaus - Universitatskliniken; 🇦🇹 Vienna, Austria

Hanuschkrankenhaus; 🇦🇹 Vienna, Austria

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

Internistische Praxis - Arnstadt; 🇩🇪 Arnstadt, Germany

Specialist Practice for Oncology; 🇩🇪 Aschaffenburg, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Kreiskrankenhaus Aurich; 🇩🇪 Aurich, Germany

Kreiskrankenhaus; 🇩🇪 Bad Hersfeld, Germany

Caritas-Krankenhaus Bad Mergentheim; 🇩🇪 Bad Mergentheim, Germany

Humaine - Clinic; 🇩🇪 Bad Saarow, Germany

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