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| Title | A prospective, multi-center phase II study of subcutaneous alemtuzumab
combined with oral dexamethasone, followed by alemtuzumab maintenance
or allogeneic stem-cell transplantation, in chronic lymphocytic leukemia
which is associated with 17p deletion or is refractory to fludarabine: CLL2O protocol of the German CLL Study Group (GCLLSG) in cooperation with the French CLL Study Group (FCLLSG) and the European Research Initiative on CLL (ERIC) |
|---|---|
| Protocol IDs | EudraCT-2007-003099-20 |
| Recruitment Status | closed |
| Design | Prospective, open-label, european, multi-centre phase II trial |
| Objectives | - Assessment of the efficacy of the study treatment in the Study Population in
terms of response rate, progression-free survival, failure-free survival and
overall survival - Acquisition of further data to expand the data base on the toxicity of the study treatment - Assessment of the efficacy of the study treatment in biological risk groups - Assessment of response in terms of minimal residual disease |
| Primary Endpoint(s) | objective response rate (ORR) |
| Secondary Endpoint(s) | - progression-free survival (PFS) - Failure-free survival (FFS) - Overall survival (OS) - Toxicity (further data) - Efficacy in biological risk groups - MRD response rate |
| Study Population | B-CLL in need of treatment - Binet C or A/B with “active disease” according to the NCI criteria - refractory to purine analogue* (cohort 1) and/or 17p deletion (cohort 2) - max. 5 different previous treatment regimens Age ≥ 18 years * Fludarabine, Pentostatin, Cladribine, Bendamustine |
| Treatment | Induction Alemtuzumab s.c. (30 mg/d 3× weekly) + Dexamethasone p.o. (40 mg/d, d1–4 + d15–18) + prophylactic Pegfilgrastim (6 mg/d, d1 + d15) q4wks; max. 3 cycles If CR or after max. 3 cycles --> Maintenance treatment (Alemtuzumab s.c., 30 mg every 14 days, max. 2 years) or allogeneic SCT (--> withdrawal from study) |
| Patients recruitedl | 137 patients (~29 with 17p deletion for first-line therapy, ~29 with 17p deletion for second- or higher-line treatment, ~ 65 fludarabine-refractory irrespective of 17p status). |
| Time schedule | study start: 01/2008 recruitment period: 30.01.2008 - 30.12.2011 |
| Protocol Version | 30.11.2007 Protocol 30.11.2007 Amendment 1 14.03.2008 Amendment 2 15.11.2009 Amendment 3 |
| Sponsor | Ulm University Hospital |
| Coordinating Investigator (D) | Prof. Dr. Stephan Stilgenbauer, Dept of Internal Medicine III, Ulm University Hospital |
| Coordinating Investigators (F) | Pr. Alain Delmer, Hématologie Clinique, Reims Pr. Florence Cymbalista, Hopital Avicenne, Bobigny |
| Contact for public queries | Wissenchaftlicher Service Pharma (WiSP), Langenfeld |
| Contact for scientific queries | Prof. Dr. Stephan Stilgenbauer, Dept of Internal Medicine II, Ulm University Hospital |
| Documents (publicly available) |
Synopsis Flowchart |
| Documents (password protected) |
Protocol, Registration Forms, Diagnostic Forms, see Download Center |