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

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

May 28, 2015

Primary Completion Date

March 9, 2022

Study Completion Date

March 9, 2022

Conditions
Chronic Lymphocytic Leucemia
Interventions
DRUG

Bendamustine

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

DRUG

GA101

"Induction: Cycle 1: d1: 100mg, d1(or2): 900mg, d8 \& 15: 1000mg; Cycle 2-6: d1: 1000mg~Maintenance: Cycle 1-8 (Duration 12 weeks): d1 1000 mg."

DRUG

CAL-101

"Induction: Cycle 2-6: d1-28: 150 mg p.o.~Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84 150 mg p.o."

Trial Locations (1)

50935

German CLL Study Group, Cologne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Gilead Sciences

INDUSTRY

lead

German CLL Study Group

OTHER