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Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia

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.
 
ClinicalTrials.gov Identifier: NCT00281892
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
German CLL Study Group

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. Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether fludarabine is more effective with or without darbepoetin alfa in treating chronic lymphocytic leukemia.

PURPOSE: This phase III trial is studying fludarabine to see how well it works when given together with or without darbepoetin alfa in treating older patients with chronic lymphocytic leukemia.


Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Anemia Biological: Fludarabine plus Darbopoetin Drug: Fludarabine mono Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the efficacy of fludarabine with or without darbepoetin alfa in geriatric patients with chronic lymphocytic leukemia and relevant comorbidities.
  • Determine the effect of these regimens in reducing anemia, lowering the requirements of transfusion, and reducing the duration and frequency of hospitalization in these patients.
  • Determine the quality of life of patients treated with these regimens.
  • Determine event-free, progression-free, and overall survival of patients treated with these regimens.
  • Evaluate the medical-economical aspects of these regimens in these patients

OUTLINE: This is a multicenter study. Patients are stratified according to hemoglobin value (< 12 g/dL [stratum 1] vs > 12 g/dL [stratum 2]). Patients are assigned to 1 of 2 treatment strata.

  • Stratum 1: Patients receive fludarabine IV on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses. Patients also receive darbepoetin alfa subcutaneously once weekly for up to 6 weeks.
  • Stratum 2: Patients receive fludarabine as in stratum 1. Quality of life is evaluated periodically.

PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity
Study Start Date : September 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : October 2010


Arm Intervention/treatment
Experimental: Fludarabine plus Darbopoetin
Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks
Biological: Fludarabine plus Darbopoetin
Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks

Active Comparator: fludarabine mono

Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support.

Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa.

Drug: Fludarabine mono

Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support.

Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa.





Primary Outcome Measures :
  1. Event-free survival [ Time Frame: up to 24 months after the last dose of study medication ]
    defined as the time from initial randomization/stratification to the time-point of progressive disease, new therapy, or death)


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 2 months after the end of the last cycle ]
    Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission

  2. toxicity [ Time Frame: 28 days after the end of the last cycle ]
    adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:

    • Previously untreated disease
    • Progressive or relapsed CLL after treatment with nonpurine analog-containing regimens as chlorambucil or bendamustine hydrochloride
  • Meets 1 of the following staging criteria:

    • Binet stage A disease with B symptoms requiring treatment
    • Binet stage B disease requiring treatment, meeting ≥ 1 of the following criteria:

      • Rapid disease progression
      • Enlarged lymph nodes and organs
      • Severe B symptoms
    • Binet stage C disease
  • Must have comorbidities (i.e., CIRS score > 6)
  • Must have restricted kidney function (i.e., creatinine clearance < 70mL/min)
  • No transformation to aggressive non-Hodgkin's lymphoma (Richter's syndrome)

PATIENT CHARACTERISTICS:

  • Life expectancy > 6 months
  • Creatinine clearance > 30 mL/min
  • No active second malignancy
  • No active bacterial, viral, or fungal infection
  • No conditions that would preclude substitution of iron
  • No severe myocardial, coronary, or respiratory insufficiency
  • No severe liver insufficiency
  • No known hypersensitivity to darbepoetin alfa
  • No cerebral dysfunction that would preclude participation in the required study procedures

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent participation in another clinical trial

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): NCT00281892


Locations
Show Show 46 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:
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Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00281892    
Other Study ID Numbers: CLL9
GCLLSG-CLL9
EU-20561
AMGEN-GCLLSG-CLL9
2005-003014-15 ( EudraCT Number )
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by German CLL Study Group:
anemia
refractory chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
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
Vidarabine
Fludarabine
Fludarabine phosphate
Darbepoetin alfa
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Hematinics