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

This study has been completed.
Sponsor:
Information provided by:
German CLL Study Group
ClinicalTrials.gov Identifier:
NCT00262782
First received: December 6, 2005
Last updated: September 22, 2016
Last verified: September 2016

December 6, 2005
September 22, 2016
April 1997
December 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00262782 on ClinicalTrials.gov Archive Site
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Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
Drug: Fludarabine
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
  • Experimental: F
    Intervention: Drug: Fludarabine
  • No Intervention: WW
    watch & wait

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
877
June 2010
December 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of B-cell chronic lymphocytic leukemia

    • Rai stage 0-II (Binet stage A) disease
  • Meets 1 of the following criteria:

    • High-risk disease, as defined by the following:

      • Serum thymidine kinase level > 7.0 U/L
      • Elevated β2-microglobulin level
      • Presence of non-nodular bone marrow infiltration
      • Short lymphocyte doubling time
    • Low-risk disease

      • Meets none of the criteria (as listed above) for high-risk disease

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • More than 6 months

Hematopoietic

  • No autoimmune hemolytic anemia
  • No thrombocytopenia

Hepatic

  • Not specified

Renal

  • Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00262782
CLL1, EU-20548, GCLLSG-138, MEDAC-GCLLSG-CLL1
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No
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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
September 2016

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