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Completed

NCT Number: NCT00281892

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Anemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg, Augsburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine plus Darbopoetin

Biological

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

Fludarabine mono

Drug

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

German CLL Study Group

Other

Registry information

Official study title

Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity

Important dates

Study start
2004
Primary completion
2008
Study completion
2010
First posted
Jan 25, 2006
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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