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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:
ClinicalTrials.gov Identifier:
NCT00262782
First Posted: December 7, 2005
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
German CLL Study Group
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia Drug: Fludarabine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by German CLL Study Group:

Enrollment: 877
Study Start Date: April 1997
Study Completion Date: June 2010
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fludarabine Drug: Fludarabine
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Other Name: Fludura
No Intervention: watch & wait

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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


  Show 117 Study Locations
Sponsors and Collaborators
German CLL Study Group
Investigators
Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00262782     History of Changes
Other Study ID Numbers: CLL1
EU-20548
GCLLSG-138
MEDAC-GCLLSG-CLL1
First Submitted: December 6, 2005
First Posted: December 7, 2005
Last Update Posted: September 13, 2017
Last Verified: September 2017
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:
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
Fludarabine phosphate
Vidarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents