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

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

January 16, 2015

Primary Completion Date

August 22, 2016

Study Completion Date

March 29, 2019

Conditions
Chronic Lymphocytic Leucemia
Interventions
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"

Trial Locations (1)

50935

German CLL Study Group, Cologne

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Janssen-Cilag Ltd.

INDUSTRY

lead

German CLL Study Group

OTHER

NCT02345863 - Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients | Biotech Hunter | Biotech Hunter