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

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ClinicalTrials.gov Identifier: NCT00262795
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
German CLL Study Group

December 6, 2005
December 7, 2005
May 15, 2018
September 2003
January 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00262795 on ClinicalTrials.gov Archive Site
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Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • 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
  • Experimental: F
    Fludarabine
    Intervention: Drug: Fludarabine
  • Active Comparator: CLB
    Chlorambucil
    Intervention: Drug: Chlorambucil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
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October 2005
January 2005   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria:

    • Binet stage A with B symptoms
    • Binet stage B or C, meeting 1 of the following criteria:

      • Rapid disease progression
      • Enlarged lymph nodes and organs
      • Severe B symptoms
  • Previously untreated disease

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • No thrombocytopenia
  • No autoimmune hemolytic anemia

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No severe organ dysfunction
  • No other prior or concurrent neoplasm

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy
Sexes Eligible for Study: All
65 Years to 79 Years   (Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
 
NCT00262795
CLL5
EU-20557
MEDAC-GCLLSG-CLL5
GCLLSG-73
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German CLL Study Group
German CLL Study Group
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Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
German CLL Study Group
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP