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Status:

COMPLETED

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

Lead Sponsor:

German CLL Study Group

Conditions:

Chronic Lymphocytic Leukemia

Eligibility:

All Genders

65-79 years

Phase:

PHASE3

Brief Summary

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. I...

Detailed Description

OBJECTIVES: Primary * Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil. * Compare t...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2005

    Estimated Enrollment :

    206 Patients enrolled

    Trial Details

    Trial ID

    NCT00262795

    Start Date

    September 1 2003

    End Date

    October 1 2005

    Last Update

    May 23 2019

    Active Locations (88)

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

    Page 1 of 22 (88 locations)

    1

    Hanuschkrankenhaus

    Vienna, Austria, A-1140

    2

    Klinikum St. Marien

    Amberg, Germany, D-92224

    3

    Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, Germany, 91522

    4

    Zentralklinikum Augsburg

    Augsburg, Germany, DOH-86156