Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

212

Participants

Timeline

Start Date

October 11, 2019

Primary Completion Date

July 31, 2029

Study Completion Date

July 31, 2030

Conditions
CLL
Interventions
DRUG

Acalabrutinib

Acalabrutinib 100 mg BID from cycle 1 day 1 for 3 cycles of 28 days.

DRUG

Venetoclax

Venetoclax, ramp up during the first five weeks starting cycle 1 day 1, 7 days treatment on each dose level (20-50-100-200-400 mg), thereafter 400 mg once daily for a total of 3 cycles of 28 days.

Trial Locations (7)

2100

RECRUITING

Rigshospitalet, Copenhagen

2730

RECRUITING

Herlev og Gentofte Hospital, Herlev

3083

RECRUITING

Ikazia Hospital (Ikazia Ziekenhuis), Rotterdam

3318

RECRUITING

Albert Schweitzer Hospital, Dordrecht

4000

RECRUITING

Sjællands Universitetshospital Roskilde, Roskilde

701 85

RECRUITING

Örebro University Hospital, Örebro

171 76

RECRUITING

Karolinska University Hospital, Stockholm

All Listed Sponsors
collaborator

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER

collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

collaborator

Karolinska Institutet

OTHER

lead

Rigshospitalet, Denmark

OTHER