NCT05004064 (CARAMEL) is a Phase 2 clinical trial of Acalabrutinib in Mantle Cell Lymphoma, sponsored by University College, London.

Who is sponsoring NCT05004064?

NCT05004064 is sponsored by University College, London.

What drugs are being tested in NCT05004064?

Interventions in NCT05004064: Acalabrutinib, Rituximab.

What condition does NCT05004064 study?

NCT05004064 studies Mantle Cell Lymphoma.

Is NCT05004064 still recruiting?

NCT05004064 is currently recruiting now. Last updated 9 April 2025.

Last reviewed 2025-04-09 · How we verify

NCT05004064: CARAMEL

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

Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma

Recruiting now Phase 2 Last updated 9 April 2025

What this trial tests

Phase 2 trial testing Acalabrutinib in Mantle Cell Lymphoma in 48 participants. Currently enrolling.

Timeline

30 November 2023

Primary endpoint
30 November 2026

1 December 2028

Quick facts

Lead sponsor	University College, London
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	30 November 2023
Primary completion	30 November 2026
Estimated completion	1 December 2028
Sites	12 locations across United Kingdom

Drugs / interventions tested

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

Conditions studied

Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

University College, London

Who can join

60 and older, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, single-arm, open-label, multicentre study of acalabrutinib and rituximab for elderly or frail patients with previously untreated mantle cell lymphoma.

Publications & conference data

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

BTK inhibitors in the treatment of hematological malignancies and inflammatory diseases: mechanisms and clinical studies.
Alu A, Lei H, Han X, Wei Y, et al · · 2022 · cited 88× · PMID 36183125 · DOI 10.1186/s13045-022-01353-w
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

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

Currently open trials in the same condition.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT06839053 — Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic L · Phase 2 · recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting
NCT06854003 — BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Fo · Phase 2 · recruiting

Other University College, London trials

Trials by the same sponsor.

NCT07386652 — Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia · NA · not yet recruiting
NCT06924086 — The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial · NA · recruiting
NCT07386678 — Study of Imaging and Molecular Biomarkers in Uncomplicated Rhegmatogenous Retinal Detachment · not yet recruiting
NCT07414940 — ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium · Phase 1, PHASE2 · not yet recruiting
NCT07214454 — TCDS for the Treatment of Chronic Migraine · NA · 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 NCT05004064 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 University College, London
Last refreshed: 9 April 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/NCT05004064.

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