DCLLSG

CLLR3 Trial

Title A prospective, multicenter, phase-II trial evaluating efficacy and safety of Bendamustine + GA101 (BG) in patients with relapsed CLL followed by maintenance therapy with GA101 for responding patients
Protocol IDs EudraCT: 2013-001088-22
NCT02320383
Status prematurely terminated due to poor accrual;
trial in follow up
Contact Medical Management: Dr. Nadine Kutsch

Dr. Nadine Kutsch
+49 221 478-88192
nadine.kutsch@uk-koeln.de

Project Management: Dr. Emily Holmes

Dr. Emily Holmes
+49 221 478-96118
emily.van-der-poel-holmes@uk-koeln.de

Data Management:
Irene Preißler-Stodden

Irene Preißler-Stodden
+49 221 478-88220
irene.stodden@uk-koeln.de

Ronald D’Brot

Ronald D’Brot
+49 221 478-89690
ronald.dbrot@uk-koeln.de

Safety Management: Tanja Annolleck

Tanja Annolleck
+49 221 478-96579
tanja.annolleck@uk-koeln.de

Contact for scientific queries Prof. Dr. Clemens Wendtner, Klinikum München Schwabing

Prof. Dr. Clemens Wendtner
+49 89 3068-2228 (Office)

Dr. Nadine Kutsch

Dr. Nadine Kutsch
+49 221 478-88192
nadine.kutsch@uk-koeln.de

Design Prospective, multicenter, open-label phase-II trial
Primary Objective To evaluate the efficacy of Bendamustine plus GA101 (BG) in patients with relapsed CLL
Primary Endpoint Overall response rate (ORR)
Secondary Endpoints - MRD levels during treatment and maintenance
- Progression free survival (PFS))
- Event-free survival (EFS)
- Overall survival (OS)
- Overall response to maintenance treatment
- Duration of response in patients with CR/ CRi, clinical
CR / clinical CRi or nPR/ PR
- Time to next anti-leukemia treatment
- Complete response rate
- Komplette Ansprechrate (Complete response rate)
- Safety parameters during induction and maintenance phase (AEs, AESI)
- Evaluation of relationship between various baseline
markers and clinical outcome parameters
- Evaluation of patients randomized into the prematurely closed FCG study arm with regard to efficacy and safety parameters
Study Population - B-CLL in need of treatment according to the iwCLL guidelinese IWCLL guidelines
- Relapsed disease
- 1 - 3 prior regimens for CLL
- no del(17p) / TP53 mutation
- not refractory to FCR/BR
- Medically fit patients without relevant comorbidity: CIRS score ≤ 6
(single score < 4 for one organ category)
- ECOG performance status ≤ 2
- Age  ≥ 18 years
Treatment Induction BG
GA101 iv
Cycle 1: d1 - 100 mg, (d1 or) d2 - 900 mg, d8+15 - 1000 mg
Cycle 2 - 6: d1 - 1000 mg
Bendamustin i.v.
Cycle 1: d3+4 (or d2+3) - 70 mg/m²
Cycle 2 - 6: d2+3 - 70 mg/m
A maximum of 6 cycles of BG will be administered; each cycle with a duration of 28 days
Maintenance GA010
After a maximum of 6 cycles of BG for patients in response (CR/ CRi, clinical CR/ CRi or nPR/ PR)

GA101 iv 1000 mg (flat dose): every 84 days starting on final restaging continued until progression or to a maximum of 2 years
Enrollment 27 patients
Time schedule Recruitment period: 11/2014 - 12/2017
Protocol Version 06 August 2014 Protocol (Version 3.11)
28 March 2015 Amendment 1 (Version 4.0)
26 November 2015 Amendment 2 (Version 5.0)
22 August 2016 Amendment 3 (Version 6.1)
Sponsor Städtisches Klinikum München GmbH
Principal Investigator Prof. Dr. med. Clemens-M. Wendtner, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie und Tropenmedizin, Klinikum Schwabing, München
Documents
(publicly available)
Synopsis
Documents
(password protected)
Protocol and other documents see Download Center