NCT02401503

Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG)

A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 and ABT-199 Followed by ABT-199 and GA101 Maintenance in CLL Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CLL2-BAG-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 ABT-199 (venetoclax, GDC-0199) followed by ABT-199 and GA101-maintenance in CLL patients

Detailed description

In the CLL2-BAG-trial, a total of 62 patients of an allcomer CLL population (irrespective of physical fitness, previous therapies and prognostic factors) with an indication for treatment will be included. Patient will receive 2 cycles of debulking treatment with Bendamustine unless contraindications (e.g. refractoriness) are present or a debulking is not indicated due to a low tumor load. Afterwards, 6 cycles of induction treatment with GA101 (obinutuzumab, 3 doses in the first cycle and monthly in cycles 2-6) and ABT-199 (venetoclax, continuously starting in cycle 2 with a low dose escalation) will be applied. The primary endpoint overall response rate will be assessed at final restaging (2 months after end of induction treatment). Patients benefitting from treatment receive further therapy with GA101 (3 monthly) and ABT-199 (continuously) in a maintenance phase for up to 24 months. Maintenance treatment will be stopped in case of achievement of a complete remission and confirmation of MRD (minimal residual disease) negativity in peripheral blood or if unacceptable toxicity or progression occurs. Since the results of the primary endpoint analysis of the CLL2-BAG trial were very promising and this trial is one of the first studies evaluating the combination of venetoclax and obinutuzumab, it is scientifically very important to follow these first patients treated with this combination as long as possible. Therefore, with amendment 4 and 5, an extended follow-up for all patients willing to continue their study participation was implemented as well as the possibility of a re-treatment with venetoclax and obinutuzumab (but without a prior bendamustine debulking) in case of a progression.

Conditions

• Chronic Lymphocytic Leucemia

Interventions

Type	Name	Description
DRUG	Bendamustine	Debulking: Cycles 1-2, d1 \& 2: 70mg/m² i.v.
DRUG	GA101	Induction: Cycle 1: d1: 100mg, d1(or 2): 900mg, d8 \& 15: 1000mg; Cycle 2-6: d1: 1000mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1: 1000mg
DRUG	ABT-199	Induction: Cycle 2: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg; Cycle 3-6: d1-28: 400mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84: 400mg

Timeline

• Start date: 2015-05-06
• Primary completion: 2024-12-10
• Completion: 2024-12-17
• First posted: 2015-03-27
• Last updated: 2025-06-10

Locations

1 site across 1 country: Germany