Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO)

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

February 4, 2016

Primary Completion Date

July 13, 2017

Study Completion Date

February 6, 2020

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Bendamustine

Debulking: Cycles 1 - 2, d1 \& 2: 70 mg/m2 i.v.

DRUG

Ofatumumab

"Induction:~Cycle 1: Day 1 300 mg i.v.; Day 8 1000 mg i.v.; Day 15 1000 mg i.v. Cycle 2-6: Day 1 1000 mg i.v.~Maintenance: After the induction ofatumumab iv 1000 mg every three months will be continued.~Cycle 1-8: Day 1 1000 mg i.v."

DRUG

Ibrutinib

Induction: Cycle 2-6: d1-28: 420 mg p.o. Maintenance: After the induction ibrutinib p.o. 420 mg daily will be continued. Cycle 1-8: d1-84: 420 mg p.o.

Trial Locations (1)

50935

German CLL Study Group, Cologne

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

German CLL Study Group

OTHER