NCT02345863

Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients

A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 and Ibrutinib (BIG) Followed by GA101 and Ibrutinib Maintenance in CLL Patients (CLL2-BIG Protocol)

• 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

A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib and GA101 maintenance in CLL patients.

Detailed description

In the CLL2-BIG trial an allcomer CLL population with indication for treatment will be included. Patient will receive 2 cycles of debulking treatment with bendamustin unless contraindications are existing or debulking is not indicated. Afterwards 6 cycles of induction therapy with GA101 and ibrutinib will be applied, each with a duration of 28 days. Primary endpoint overall Response rate will be assessed at final restaging. Patients benefitting from BIG treatment will enter the maintenance phase of the trial. Maintenance treatment will be continued if no unacceptable toxicity occurs until three months after negativity of minimal residual disease \[MRD\] is achieved in peripheral blood in patients with (clinical) complete response (CR) or (clinical) incomplete complete response \[CRi\] (confirmed by 2 consecutive testings of MRD within 3 months), progression of CLL, start of a subsequent therapy or up to 8 cycles of maintenance (each cycle with a duration of 84 calendar days = 3 months), whichever occurs first.

Conditions

• Chronic Lymphocytic Leucemia

Interventions

Type	Name	Description
DRUG	Bendamustine	Debulking: 2 cycles of Bendamustine (70 mg/m² iv) will be administered before induction unless a contraindication is existing or it is not clinically indicated.
DRUG	GA101	Induction GA101 iv infusion: Cycle 1: Day 1 100 mg Day 1 (or 2) 900 mg Day 8 1000 mg Day 15 1000 mg Cycle 2-6: Day 1 1000 mg Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued. GA101: Cycle 1-8 Day 1 1000 mg
DRUG	Ibrutinib	Ibrutinib will be administered as a daily oral dosage of 420 mg starting on cycle 2 day 1. Cycle 2-6: Day 1 420 mg daily Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued. Ibrutinib: Cycle 1-8 420 mg daily

Timeline

• Start date: 2015-01-16
• Primary completion: 2016-08-22
• Completion: 2019-03-29
• First posted: 2015-01-26
• Last updated: 2019-05-08

Locations

1 site across 1 country: Germany