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| Title | Darbepoetin alfa in patients with chronic lymphocytic leukamia and comorbidity |
|---|---|
| Protocol IDs | EUDRACT-2005-003014-15 NCT00281892 (24 Jan 2006) |
| Participating Countries | Germany |
| Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospective, open-label, multicentre, randomised, phase III trial |
| Objective | Evaluation of safety and effectiveness of the erythropoiesis stimulating protein Darbepoetin alfa as supportive treatment in patients with treatment requiring CLL and relevant comorbidities undergoing chemotherapy with fludarabine |
| Primary Endpoint(s) | Event-free survival (EFS) |
| Secondary Endpoints | - Severity of anemia - Survival without requirement of transfusions - Quality of life - Duration and frequency of hospitalization - Overall survival (OS), progression-free survival (PFS) - Rates of complete and partial remissions (CR/PR) - Toxicity - Medical-economical aspects |
| Study Population | B-CLL, Binet-Stage C or B/A with need for treatment Relvant comorbidities (CIRS-score more than 6) No pretreatment or progressive/relapsed CLL after treatment with regimens not containing purine analogs (e.g. Chlorambucil, Bendamustine) |
| Treatment | Fludarabine-Therapy (all patients): Fludarabine i.v. (30 mg/m²/d, d1,3, 5) q28d, max 6 cycles or alternatively for patients outside Germany: Fludarabine p.o. (48 mg/m²/d, d1,3, 5) q28d, max 6 cycles |
| Darbepoetin-Arm: Darbepoetin alfa s.c. (500/300µg according to response, d1) q21d, max. until end of chemotherapy (500µg, q21d / 300µg, q14d / 300µg, q7d - arbitrary interval between applications with defined initial dose, Hb-dependent dose titration) |
|
| Patients recruited | 97 patients |
| Time schedule | Recruitment period: 08 Dec 2004 - 16 Apr 2008
End of study: Oct 2010 Clinical Study Report / Publication: Aug 2015 End of archiving period: Oct 2020 |
| Sponsor | German CLL Study Group (GCLLSG) |
| Coordinating Investigator | Prof. Dr. Michael Hallek, Internal Medicine I, University Hospital of Cologne |
| Publications | Goede V, Bahlo J, Chataline V, Eichhorst B, Dürig 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. 2015 Sep 17:1-21 [Epub ahead of print] Goede V, Busch R, Bahlo J, Chataline V, Kremers S, Müller 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. 2015 Aug 21:1-22. [Epub ahead of print] |