Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 65	Other, Pharmaceutical / Industry	GCLLSG-CLL4 EU-20538, GCLLSG-153, ISRCTN75653261, MEDAC-GCLLSG-CLL4, NCT00276848

Objectives

Primary

1. 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

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

Entry Criteria

Disease Characteristics:

• Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL)
  • Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms
  • Binet stage A is acceptable, if there are B-symptoms

Prior/Concurrent Therapy:

• No prior or concurrent chemotherapy

Patient Characteristics:

• ECOG performance status 0-2
• Life expectancy > 6 months
• No severe organ dysfunction
• No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia

Expected Enrollment

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

Outcomes

Progression-free survival
Overall survival
Duration of remission

Incidence of side effects
Quality of life

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.

Eichhorst BF, Busch R, Obwandner T, et al.: Health-related quality of life in younger patients with chronic lymphocytic leukemia treated with fludarabine plus cyclophosphamide or fludarabine alone for first-line therapy: a study by the German CLL Study Group. J Clin Oncol 25 (13): 1722-31, 2007.[PUBMED Abstract]

Eichhorst BF, Busch R, Hopfinger G, et al.: Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood 107 (3): 885-91, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

German CLL Study Group

Michael Hallek, MD, Protocol chair		Ph: 49-221-478-4400

Registry Information
Official Title		Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
Trial Start Date		1999-07-01
Registered in ClinicalTrials.gov		NCT00276848
Date Submitted to PDQ		2005-09-30
Information Last Verified		2007-04-09

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