M24-287 Venetoclax in Combination with Obinutuzumab or Acalabrutinib - CLL
Research type
Research Study
Full title
A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination with Obinutuzumab or Acalabrutinib With Different Ramp-Up Periods in Previously Untreated Subjects with CLL
IRAS ID
1010172
Contact name
Alice Butler
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2024-512147-23
Clinicaltrials.gov Identifier
Research summary
Chronic lymphocytic leukemia (CLL) is the most commonleukemia (cancer of blood cells). The purpose of this studyis to assess the safety of venetoclax in combination withobinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be
assessed.
Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumabor oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide.
Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5week venetoclax ramp up. Participants in Arm C and ArmD will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months.REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0175
Date of REC Opinion
3 Sep 2024
REC opinion
Further Information Favourable Opinion