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Status:

COMPLETED

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

Lead Sponsor:

German CLL Study Group

Conditions:

Chronic Lymphocytic Leukemia

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

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 can...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 1997

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2010

    Estimated Enrollment :

    877 Patients enrolled

    Trial Details

    Trial ID

    NCT00262782

    Start Date

    April 1 1997

    End Date

    June 1 2010

    Last Update

    February 20 2020

    Active Locations (117)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 30 (117 locations)

    1

    Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

    Vienna, Austria, 1090

    2

    Hanuschkrankenhaus

    Vienna, Austria, A-1140

    3

    Klinikum St. Marien

    Amberg, Germany, D-92224

    4

    Internistische Praxis - Arnstadt

    Arnstadt, Germany, 99310