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Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity


Phase 3
N/A
N/A
Open (Enrolling)
Both
Anemia, Leukemia

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Trial Information

Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Michael Hallek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medizinische Universitaetsklinik I at the University of Cologne

Authority:

Unspecified

Study ID:

CDR0000454570

NCT ID:

NCT00281892

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Anemia
  • Leukemia
  • 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
  • Anemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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