DCLLSG

CLL2-BCG Trial

Title A prospective, open-label, multicenter phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and GA101 maintenance in CLL patients
Protocol IDs EudraCT: 2014-000582-47
NCT02445131
Status Recruiting
Contact Medical Management: Dr. Paula Cramer

Dr. Paula Cramer
+49 221 478-88220 (Office)
paula.cramer@uk-koeln.de

Project Management: Miriam Schüler-Aparicio

Miriam Schüler-Aparicio
+49 221 478-96119
miriam.schueler-aparicio@uk-koeln.de

Data Management: Olga Korf

Olga Korf
+49 221 478-96124
olga.korf@uk-koeln.de

Safety Management: Verena Bonigut

Verena Bonigut
+49 221 478-96578
verena.bonigut@uk-koeln.de

Contact for scientific queries Dr. Paula Cramer

Dr. Paula Cramer
+49 221 478-88220 (Office)
paula.cramer@uk-koeln.de

Design Prospective, multicenter, single-arm, open-label phase-II trial
Objective To evaluate the efficacy and the safety of the therapeutic regimen
Primary Endpoint Overall response rate (ORR) at final restaging (RE) including all patients achieving CR, CRi or PR
Secondary Endpoints - Safety parameters: AEs, AESI and their relationship to study treatment
- MRD levels measured in peripheral blood
- Best response rate (BRR) until 6 months after RE
- ORR and (clinical) CR/CRi rate after debulking, at the final restaging (RE), after the end of maintenance treatment and in biological defined risk groups
- Progression-free survival (PFS)
- Event-free survival (EFS)
- Overall survival (OS)
- Duration of response, treatment free survival and time to next treatment
- Evaluation of relationship between various baseline markers and clinical outcome parameters
Target Population Relapsed/refractory CLL according to iwCLL criteria, requiring treatment, with at least one of the following features:
     - del(17p)/TP53 mutation
     - ineligibility for ibrutinib due to refractoriness, intolerance or contraindications to receive ibrutinib
Patients, must have recovered
ECOG performance status 0 – 2 (ECOG 3 only permitted if related to CLL)
Age  ≥ 18 years
Treatment Debulking
2 debulking cycles of bendamustine will be administered unless the patient has a contraindication or a debulking is not clinically indicated
Bendamustin i.v.
Cycle 1 - 2: 70 mg/m², d1-2
q 28d
Induction
6 cycles; q 28d
GA101
(Obinutuzumab) i.v.
Cycle 1: d1 - 100 mg, d1 (or d2) - 900 mg, d8 + d15 - 1000 mg
Cycle 2 - 6: 1000 mg, d1
CAL-101 (Idelalisib) p.o.
Cycle 1: --
Cycle 2 - 6: 150 mg (1 tabl.) 1-0-1 daily

During the phase of staging between induction and maintenance the intake of CAL-101 is continued.
Maintenance
GA101 (Obinutuzumab) i.v.
Cycle 1 - 8: 1000 mg, d1
CAL-101 (Idelalisib) p.o.
Cycle 1 - 8: 150 mg (1 tabl.) 1-0-1 daily
q 84d

Maintenance treatment will be continued until (whichever occurs first):
- 3 months after confirmation of achievement of MRD negativity in patients with a (clinical) CR/CRi,
- progression of CLL or start of a subsequent therapy
- unacceptable toxicity
- maintenance cycle 8
Targeted Accrual Approximately 41 eligible patients
Time schedule Start of recruitment: Q2/2015
Expected End of recruitment: Q2/2017
End of study: Q4/2020
Protocol Version 1st April 2015 Protocol (Version 2.2)
09 November 2015 Amendment 1 (Version 3.0)
13 June 2016 Amendment 2 (Version 4.0)
Sponsor University of Cologne
Global Principal Investigator Dr. med. Paula Cramer, Department I of Internal Medicine, University Hospital of Cologne
Coordinating Physician Dr. med. Julia v. Tresckow, Department I of Internal Medicine, University Hospital of Cologne
Documents
(publicly available)
Synopsis
Documents
(password protected)
Protocol and other documents see Download Center