drugset / Trial / NCT05951959

A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma

NCT05951959

Phase 2 Active not recruiting 108 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule Oral
Subject Rituximab Monoclonal antibody Intravenous
Subject Venetoclax Small molecule Oral

Indications