Sprung-Navigation
| 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 | in follow up |
| Contact | Medical Management: Dr. Paula Cramer Dr. Paula Cramer Angelina Glatt Olga Korf Berit Falkowski |
| Contact for scientific queries | Dr. Paula Cramer Dr. Paula Cramer |
| 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 |
|
| Patients recruitedl | 48 patients |
| Time schedule | Recruitment period: 28 May 2015 - 04 June 2019 End of study: Q1/2022 |
| 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) 21 May 2019 Amendment 5 (Version 5.0) 20 Apr 2020 Amendment 6 (Version 6.0) |
| Sponsor | University of Cologne |
| Global Principal Investigator | Dr. med. Paula Cramer, Department I of Internal Medicine, University Hospital of Cologne |
| Coordinating Physician | Dr. med. Anna-Maria Fink, Department I of Internal Medicine, University Hospital of Cologne |
| Documents (password protected) |
Protocol and other documents see Download Center |