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Clinical Trial Active — Not Recruiting Phase II NCT05951959

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

A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma — Active Not Recruiting • Phase II • NCT05951959.

📅 01 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase II
NCT ID
NCT05951959
Start
2023-12-13
Completion
2028-10-31
ClinicaliQ Trial Snapshot
  • A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma — Active Not Recruiting • Phase II • NCT05951959.
  • TrAVeRse Trial Summary.
  • Acalabrutinib, venetoclax and rituximab combination therapy for untreated mantle cell lymphoma, testing whether maintenance treatment improves outcomes.

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What This Trial Is Studying

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 Conditions: Mantle Cell Lymphoma (MCL) Interventions: Acalabrutinib, Venetoclax, Rituximab Lead Sponsor: AstraZeneca Planned Enrollment: 108 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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