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NCT05951959 · ClinicalTrials.gov record · last posted 2026-06-01

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

Study acronym: TrAVeRse
StatusActive, Not Recruiting
PhasePhase 2
Started2023-12-13
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from the ClinicalTrials.gov record
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

Amendment record 11 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 11 times since 2023-07-17; most recent amendment 2026-05-28. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-07-12
Status change Recruiting→Active, Not Recruitingv5
2024-01-12
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT05951959
Lead Sponsor AstraZeneca
Conditions Mantle Cell Lymphoma (MCL)
Enrollment 108 participants
Start Date 2023-12-13
Primary Completion 2028-10-31 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-01