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

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ClinicalTrials.gov Identifier: NCT00262782
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
German CLL Study Group

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Fludarabine Phase 3

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
Study Start Date : April 1997
Actual Primary Completion Date : December 2004
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fludarabine Drug: Fludarabine
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Other Name: Fludura
No Intervention: watch & wait


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262782


Locations
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Sponsors and Collaborators
German CLL Study Group
Investigators
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Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
More Information
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Additional Information:

Publications of Results:
Bergmann MA, Eichhorst BF, Busch R, et al.: Early and risk-adapted therapy with fludarabine in high-risk Binet stage A CLL patients prolongs progression free survival but not overall survival: results of the CLL1 protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-2038, 2007.
Bergmann MA, Eichhorst BF, Busch R, et al.: Prospective evaluation of prognostic parameters in early stage chronic lymphocytic leukemia (CLL): results of the CLL1-protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-625, 2007.

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00262782    
Other Study ID Numbers: CLL1
EU-20548
GCLLSG-138
MEDAC-GCLLSG-CLL1
First Posted: December 7, 2005    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by German CLL Study Group:
B-cell chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine
Antineoplastic Agents