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Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00276848
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
German CLL Study Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.


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

Detailed Description:

OBJECTIVES:

Primary

  • Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide.

Secondary

  • Compare the incidence of side effects and quality of life of patients treated with these drugs.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms

  • Arm I: Patients receive fludarabine IV on days 1-5.
  • Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
Study Start Date : July 1999
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2007


Arm Intervention/treatment
Active Comparator: Fludarabine plus Cyclophosphamide Drug: Fludarabine plus Cyclophosphamide
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses

Active Comparator: Fludarabine Drug: Fludarabine
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 18 Month after end of treatment of the last patient ]
    date of randomization until progression of disease or death of any cause

  2. Overall survival [ Time Frame: 18 Month after end of treatment of the last patient ]
    Date of randomization until date of death

  3. Duration of remission [ Time Frame: 18 Month after end of treatment of the last patient ]
    Clinical response was defined according to the guidelines of the NCI-sponsored workshop


Secondary Outcome Measures :
  1. Incidence of side effects [ Time Frame: up to 28 days after the last dose of study medication ]
    Toxic effects of treatment were evaluated according to the Common Toxicity Criteria (CTC 1.0)

  2. Quality of life [ Time Frame: 18 Month after end of treatment of the last patient ]
    EORTC QUOL Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL)

    • Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms
    • Binet stage A is acceptable, if there are B-symptoms

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • No severe organ dysfunction
  • No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia

PRIOR CONCURRENT THERAPY:

  • No prior or concurrent chemotherapy

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): NCT00276848


  Show 135 Study Locations
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

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00276848     History of Changes
Other Study ID Numbers: CLL4
EU-20538
GCLLSG-153
ISRCTN75653261
MEDAC-GCLLSG-CLL4
CDR0000455094 ( Other Identifier: Clinical Data Repository )
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by German CLL Study Group:
stage III chronic lymphocytic leukemia
stage IV 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
Cyclophosphamide
Fludarabine phosphate
Fludarabine
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents