Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG)

Phase 2 Completed 48 enrolled German CLL Study Group Gilead Sciences · collab Hoffmann-La Roche · collab

NaSingle-groupOpen-labelTreatment

Summary

The CLL2-BCG-trial is a prospective, open-label, multicenter phase-II-trial to evaluate the efficacy and safety of a sequential regimen of a debulking with bendamustine followed by an induction with GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and GA101-maintenance in CLL patients

Timeline

Start: 2015-05-28
Primary completion: 2022-03-09
Completion: 2022-03-09

Publications

Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	70 mg/m2	Intravenous
Subject	Idelalisib	Small molecule	150 mg	Oral
Subject	Obinutuzumab	Monoclonal antibody	1000 mg	—

Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG)

Summary

Timeline

Publications

Drugs

Indications