CLL2O Trial

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 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
(publicly available)
(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