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| Title | A Placebo-Controlled, Double-Blind, Randomized, Multicenter, Three Arm Phase III Trial to Compare the Efficacy and Safety of Ibrutinib vs. Placebo in Previously Untreated Binet Stage A CLL Patients with Risk of Early Disease Progression |
|---|---|
| Protocol IDs | EudraCT: 2013-003211-22 NCT02863718 |
| Status | in follow up |
| Contact | Medical Management: Dr. Petra Langerbeins Dr. Petra Langerbeins Marie Kronmüller Henrik Gerwin Tanja Annolleck |
| Contact for scientific queries | Dr. Petra Langerbeins Dr. Petra Langerbeins |
| Design | Prospective, placebo-controlled, double-blind, randomized, multicenter, three-arm phase III study |
| Primary Endpoint(s) | Event-free survival (EFS) |
| Secondary Endpoints | Main secondary endpoint: - Overall survival (OS) Other secondary endpoints: - Progression-free survival (PFS) - Treatment-free survival (TFS) - Type, response and duration of response to subsequent treatment for CLL - overall response rate (ORR), complete response (CR) and partial response (PR) - Evaluation and comparison of the safety profile of patients treated with ibrutinib - Assessment of medication-taking behavior by Morisky 8 (MMAS-8) - Time to first CLL treatment (TTFT) - Health-related quality of life by EORTC QLQ-C30 and QLQ-CLL16 |
| Study Population | Previously untreated B-CLL according to the IWCLL guidelines Stage Binet A without need for treatment Age ≥ 18 years ECOG performance status 0 – 2 |
| Treatment | Arm I (Patients with low risk of early progression): watch & wait |
| Arm II (Patients with intermediate to very high risk of early progression) Placebo 420mg/d |
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| Arm III(Patients with intermediate to very high risk of early progression) Ibrutinib 420mg/d |
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| Patients recruited | 515 patients |
| Time schedule | Recruitment period: 30 Apr 2014 - 15 Feb 2019 End of study: Q3/2021 |
| Protocol Version | Protocol (Version 1.1 | 18 March 2014) Amendment 1 (Version 2.0 | 15 Sept. 2014) Amendment 2 (Version 3.0 | 20 Jan. 2015) Amendment 3 (Version 4.0 | 20 Jun. 2015) Amendment 4 (Version 5.1 | 21 Dec. 2015) Amendment 5 (no new protocol version) Amendment 6 (Version 6.1 | 01 March 2017) Amendment 7 (no new protocol version) Amendment 9 (Version 8.0 | 02 Dec 2019) |
| Sponsor | University of Cologne |
| Principal Investigator | Dr. Petra Langerbeins, Internal Medicine I, University Hospital of Cologne |
| Documents (password protected) |
Forms and other documents see Download Center |
| Publications | Langerbeins P, Bahlo J, Rhein C, Cramer P, Pflug N, Fischer K, Stilgenbauer S, Kreuzer KA, Wendtner CM, Eichhorst B, Hallek M The CLL12 trial protocol: a placebo-controlled double-blind Phase III study of ibrutinib in the treatment of early-stage chronic lymphocytic leukemia patients with risk of early disease progression Future Oncol. 2015 Jul;11(13):1895-903 |