Ibrutinib lead-in Followed by Venetoclax Plus Ibrutinib in Patients With RR CLL

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 11, 2019

Primary Completion Date

April 30, 2026

Study Completion Date

December 31, 2026

Conditions
Relapsed/Refractory Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaLeukemia
Interventions
DRUG

Ibrutinib

"Patients receive 6 cycles (cycle = 28 days) of ibrutinib monotherapy at the daily dose of 420 mg (3x 140 mg).~Venetoclax is added on ibrutinib treatment starting from cycle 7 as weekly dose ramp-up (20 mg, C7 day 1-7; 50 mg, C7 day 8-14; 100 mg, C7 day 15-21; 200 mg, C7 day 22-28; 400 mg, C8-31 day 1-28).~Venetoclax (400 mg d1-28) and ibrutinib (420 mg d1-28) continue until cycle 31. Depending on MRD-neg CR/CRi patients will continue the combination treatment (maintenance) or stop treatment (observation) up to 5 years after cycle 31."

DRUG

Venetoclax

"Venetoclax is added on ibrutinib treatment starting from cycle 7 as weekly dose ramp-up (20 mg, C7 day 1-7; 50 mg, C7 day 8-14; 100 mg, C7 day 15-21; 200 mg, C7 day 22-28; 400 mg, C8-31 day 1-28).~Venetoclax (400 mg d1-28) and ibrutinib (420 mg d1-28) continue until cycle 31. Depending on MRD-neg CR/CRi patients will continue the combination treatment (maintenance) or stop treatment (observation) up to 5 years after cycle 31."

Trial Locations (11)

3010

Inselspital, Bern

3600

Spital STS AG Thun, Thun

4031

Universitätsspital Basel, Basel

6000

Luzerner Kantonsspital, Lucerne

6501

IOSI - Ospedale San Giovanni, Bellinzona

7000

Kantonsspital Graubünden, Chur

8091

Universitätsspital Zürich, Zurich

8401

Kantonsspital Winterthur, Winterthur

8596

Kantonsspital Münsterlingen, Münsterlingen

CH-5001

Kantonsspital Aarau, Aarau

CH-4410

Kantonsspital Liestal, Liestal

All Listed Sponsors
lead

Swiss Cancer Institute

OTHER

NCT03708003 - Ibrutinib lead-in Followed by Venetoclax Plus Ibrutinib in Patients With RR CLL | Biotech Hunter | Biotech Hunter