Clinical trial · Interventional
Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia
Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity
NCT00281892CI-TRIAL-00032868completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine mono | Drug | — | UNRESOLVED |
| Fludarabine plus Darbopoetin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fludarabine plus Darbopoetin
- description
- 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
- interventionNames
- Biological: Fludarabine plus Darbopoetin
- type
- ACTIVE_COMPARATOR
- label
- fludarabine mono
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 trialReferences
Publications (2)
- RESULTGoede V, Busch R, Bahlo J, Chataline V, Kremers S, Muller L, Reschke D, Schlag R, Schmidt B, Vehling-Kaiser U, Wedding U, Stilgenbauer S, Hallek M. Low-dose fludarabine with or without darbepoetin alfa in patients with chronic lymphocytic leukemia and comorbidity: primary results of the CLL9 trial of the German CLL Study Group. Leuk Lymphoma. 2016;57(3):596-603. doi: 10.3109/10428194.2015.1079314. Epub 2015 Oct 12. PMID 26293380
- RESULTGoede V, Bahlo J, Chataline V, Eichhorst B, Durig J, Stilgenbauer S, Kolb G, Honecker F, Wedding U, Hallek M. Evaluation of geriatric assessment in patients with chronic lymphocytic leukemia: Results of the CLL9 trial of the German CLL study group. Leuk Lymphoma. 2016;57(4):789-96. doi: 10.3109/10428194.2015.1091933. Epub 2015 Oct 13. PMID 26377031