drugset / Trial / NCT05951959
A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
TrAVeRse is a multicentre, open-label, Phase II study of AVR in treatment naïve MCL participants. The primary objective will be to assess the rate of MRD-negative CR at end of induction after completing 13 cycles of AVR. Participants achieving an MRD-negative CR at the end of AVR induction will be randomised to continued acalabrutinib or observation. Participants who progress during observation may receive retreatment with acalabrutinib
Timeline
- Start
- 2023-12-13
- Primary completion
- 2028-10-31
- Completion
- 2028-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | — | Oral |
| Subject | Rituximab | Monoclonal antibody | — | Intravenous |
| Subject | Venetoclax | Small molecule | — | Oral |