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| Title | Multicenter phase II trial of fludarabine and cyclophosphamide in combination with alemtuzumab for patients with relapsed or high risk chronic lymphocytic leukemia (FC-Cam) |
|---|---|
| Protocol IDs | EudraCT2005-003017-32 NCT00147901 (02 Sep 2005) |
| Participating Countries | Germany |
| Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospektive, open-label, multicentre, non-randomized phase II trial |
| Primary Endpoint(s) | overall response rate (ORR) |
| Secondary Endpoint(s) | - overall response rate in biological defined risk groups - duration of response - event-free survival - MRD response rate - complete response rate - toxicity - treatment administration |
| Study Population | High risk primary B-CLL (17p- deletion) or relapsed or refractory B-CLL with at least 1, max 4 prior regimens Age ≥ 18 years |
| Treatment | Dose escalation: Alemtuzumab s.c. 3/10 mg within 1 week Therapy: Alemtuzumab s.c. (30 mg/d, d1-3) Fludarabine i.v. 25 mg/m²/d, d1-3) + Cyclophosphamide i.v. (200 mg/m²/d, d1-3) q28d; 3 - 6 cycles |
| Patients recruited | 61 patients |
| Time schedule | Recruitment period: 08 Mar 2005 - 21 Nov 2008 End of study: Mar 2012 Clinical Study Report / Publication: May. 2012 End of archiving period: Mar 2022 |
| Sponsor | University of Cologne (GCLLSG) |
| Coordinating Investigator | Prof. Dr. Andreas Engert, Internal Medicine I, University Hospital of Cologne |
| Publications | Elter T, James R, Busch R, Winkler D, Ritgen M, Böttcher S, Kahl C, Gassmann W, Stauch M, Hasan I, Staib P, Fischer K, Fink AM, Bahlo J, Bühler A, Döhner H, Wendtner CM, Stilgenbauer S, Engert A, Hallek M writtrn on behalf of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) Fludarabine and cyclophosphamide in combination with alemtuzumab (FCCam) in patients with primary high-risk, relapsed or refractory chronic lymphocytic leukemia Leukemia. 2012 Dec;26(12):2549-52 |