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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 NCT01392079 |
| 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 | 131 patients: 42 pts. with 17p deletion for first-line therapy, 28 pts. with 17p deletion for second- or higher-line treatment, 61 pts. 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 and Forms, see Download Center |
| Publications | Steinbrecher D, Jebaraj BMC, Schneider C, Edelmann J, Cymbalista F, Leblond V, Delmer A, Ibach S, Tausch E, Scheffold A, Bloehdorn J, Hallek M, Dreger P, Döhner H, Stilgenbauer S Telomere length in poor-risk chronic lymphocytic leukemia: associations with disease characteristics and outcome Leuk Lymphoma. 2017 Oct 24:1. doi: 10.1080/10428194.2017.1390236. [Epub ahead of print] Stilgenbauer S, Cymbalista F, Leblond V, Delmer A, Ibach S, Choquet S, Dartigeas C, Cazin B, Tournilhac O, Pegourie B, Seiler TM, Sökler M, Zirlik K, Alt J, Huber H, Bloehdorn J, Tausch E, Zenz T, Hallek M, Schetelig J, Dreger P, Döhner H Alemtuzumab combined with dexamethasone, followed by alemtuzumab maintenance or Allo-SCT in “ultra High-risk” CLL: final results from the CLL2O phase II study Blood. 2014;124:1991 |