NCT05951959 (TrAVeRse) is a Phase 2 clinical trial of Acalabrutinib in Mantle Cell Lymphoma (MCL), sponsored by AstraZeneca.

Who is sponsoring NCT05951959?

NCT05951959 is sponsored by AstraZeneca.

What drugs are being tested in NCT05951959?

Interventions in NCT05951959: Acalabrutinib, Venetoclax, Rituximab.

What condition does NCT05951959 study?

NCT05951959 studies Mantle Cell Lymphoma (MCL).

Is NCT05951959 still recruiting?

NCT05951959 is currently active, enrolled. Last updated 21 October 2025.

Last reviewed 2025-10-21 · How we verify

NCT05951959: TrAVeRse

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 21 October 2025

What this trial tests

Phase 2 trial testing Acalabrutinib in Mantle Cell Lymphoma (MCL) in 108 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 December 2023

Primary endpoint
7 July 2028

7 July 2028

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	108
Start date	13 December 2023
Primary completion	7 July 2028
Estimated completion	7 July 2028
Sites	29 locations across United Kingdom, Poland, Canada, Australia, Spain, United States, Brazil

Drugs / interventions tested

Acalabrutinib (ACALABRUTINIB) — full drug profile →
Venetoclax (venetoclax) — full drug profile →
Rituximab — full drug profile →

Conditions studied

Mantle Cell Lymphoma (MCL) — all drugs for Mantle Cell Lymphoma (MCL) →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, any sex, with Mantle Cell Lymphoma (MCL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Acalabrutinib plus venetoclax and rituximab in treatment-naive mantle cell lymphoma: 2-year safety and efficacy analysis.
Wang M, Robak T, Maddocks KJ, Phillips T, et al · · 2024 · cited 20× · PMID 38781315 · DOI 10.1182/bloodadvances.2023012424
Updates on the Biological Heterogeneity of Mantle Cell Lymphoma.
Ip A, Kabat M, Fogel L, Alkhatatneh H, et al · · 2025 · cited 1× · PMID 40002289 · DOI 10.3390/cancers17040696
Your chemo is no good here: management of high-risk MCL.
Sawalha Y, Maddocks K. · · 2024 · cited 1× · PMID 39644043 · DOI 10.1182/hematology.2024000658
Evolving therapeutic strategies in mantle cell lymphoma: advancements and future directions.
Tavarozzi R, Maher N, Catania G, Zacchi G, et al · · 2026 · PMID 41986622 · DOI 10.1038/s41375-026-02942-1
MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma.
Ruan J, Bond DA, Shah B, Allan JN, et al · · 2026 · PMID 41289154 · DOI 10.1182/bloodadvances.2025017760

Verify or expand the search:

Other trials of Acalabrutinib

Trials testing the same drug.

NCT07257055 — Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WIN · Phase 2 · recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07024706 — Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2 · Phase 2 · not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting

Other recruiting trials for Mantle Cell Lymphoma (MCL)

Currently open trials in the same condition.

NCT07077512 — Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma · Phase 2 · recruiting
NCT07272499 — Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease · Phase 2 · recruiting
NCT07257510 — Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma · NA · recruiting
NCT07199296 — Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment · Phase 2 · recruiting
NCT06846489 — Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lym · Phase 2 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05951959 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 21 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05951959.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing