Sprung-Navigation
| Title | Consolidation therapy with Alemtuzumab ( MabCampath ®) in patients with chronic lymphocytic leukemia who are in complete or partial 2nd remission after cytoreduction with fludarabine or fludarabine plus cyclophosphamide or fludarabine plus cyclophosphamide plus rituximab or bendamustine or bendamustine plus rituximab - a phase I/II study |
|---|---|
| Protocol IDs | NCT00634881 (12 Mar 2008) |
| Participating Countries | Germany |
| Status | completed |
| Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
| Design | Prospective, open-label, oligocentric two cohort dose escalation phase I/II trial |
| Primary Endpoint(s) | - Dose-limiting toxicity (DLT) - Maximal tolerable dose (MTD) |
| Secondary Endpoint(s) | - Complete MRD response - Immunophenotypic remission - Infections and side effects - Pharmacokinetics of alemtuzumab ( i.v. and s.c.) - Progression-free survival, overall survival - CR rate (clinical remission) |
| Study Population | B-CLL in complete or partial 2nd remission after F/FC/FCR/B/BR chemotherapy Max 2 prior chemotherapies (including F/FC/FCR/B/BR-therapy) Age ≥ 18 years |
| Treatment | Cohort A (Alemtuzumab i.v.): Dose level I: 10 mg/week (dose escalation starting with 3 mg) Dose level II: 20 mg/week (dose escalation starting with 3 mg) Dose level III: 30 mg/week (dose escalation starting with 3 mg) max 8 weeks |
| Cohort B (Alemtuzumab s.c.): Dose escalation (s.c.) is performed according to the same escalation rules as for cohort A, starting with the recommended dose level of i.v. application |
|
| Patients recruited | 13 patients |
| Time schedule | Recruitment period: 28.11.2003 - 14.11.2007 End of study: Feb 2012 Clinical Study Report / Publication: Mar 2017 End of archiving period: Feb 2022 |
| Sponsor | DCLLSG/München/Prof. Clemens Wendtner |
| Coordinating Investigator | Prof. Dr. M. Hallek, Internal Medicine I, University Hospital of Cologne |
| Publications | Al-Sawaf O, Fischer K, Herling CD, Ritgen M, Böttcher S, Bahlo J, Elter T, Stilgenbauer S, Eichhorst BF, Busch R, Elberskirch U, Abenhardt W, Kneba M, Hallek M, Wendtner CM Alemtuzumab consolidation in chronic lymphocytic leukaemia: A phase I/II multicentre trial Eur J Haematol. 2017 Mar;98(3):254-262 |