TrAVeRse
Research type
Research Study
Full title
A Multicentre, Phase II, Randomised, Open-label Study to Evaluate the Efficacy of Acalabrutinib in Combination with Venetoclax and Rituximab in Participants with Treatment Naïve Mantle Cell Lymphoma (TrAVeRse)
IRAS ID
1008357
Contact name
Yehan Wijesinghe
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2023-505205-16
Clinicaltrials.gov Identifier
Research summary
The TrAVeRse study is for patients with Mantle Cell Lymphoma (MCL) that have not yet received treatment. It will assess a non-chemotherapy treatment combination of 3 anti-cancer drugs; acalabrutinib, venetoclax, and rituximab (AVR) as a first treatment. The drugs are designed to kill or stop cancer cells growing. In this study, researchers want to learn how safe and effective AVR is when treating MCL, and whether continued acalabrutinib treatment in participants with no signs of cancer after AVR treatment can prevent their cancer returning.
Design, treatment and procedures:
The study is open label, meaning participants, trial doctors and trial staff will know the treatment participants are receiving. Treatment with AVR will last 12 months, split into 13 cycles of 28 days. Acalabrutinib will be taken by mouth twice daily from day 1 of treatment, rituximab will be received through a needle, directly into the vein (IV infusion) once every 28 days for the first 12 cycles and venetoclax will be taken by mouth from day one of cycle 2 for 12 cycles.
Following AVR treatment, participants without any signs of MCL will be randomized with an equal chance of being randomised to either continued treatment with acalabrutinib or to observation only (no anti-cancer treatment). Participants randomised to observation may be retreated with acalabrutinib if their cancer returns.
Participants will be regularly monitored throughout the study for safety and to check whether the treatment is working, with monthly visits during AVR and 3 or 6 monthly visits thereafter.
The study will enroll 100 participants from cancer centres in the UK, US, Australia, Canada and Europe and will last up to 67 months.
Potential benefits:
All participants will help researchers learn more about AVR and MCL whilst potentially benefiting from access to a chemotherapy-free treatment for MCL.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0929
Date of REC Opinion
4 Dec 2023
REC opinion
Further Information Favourable Opinion