Status:
COMPLETED
Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Anemia
Eligibility:
All Genders
Phase:
PHASE3
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 m...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00281892
Start Date
September 1 2004
End Date
October 1 2010
Last Update
May 11 2018
Active Locations (46)
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1
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Augsburg, Germany, 86150
2
Onkologische Schwerpunktpraxis und Tagesklinik Dres
Bad Soden, Germany, 65812
3
Internistische Gemeinschaftspraxis - Berlin
Berlin, Germany, 13347
4
Charite - Campus Charite Mitte
Berlin, Germany, D-10117