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Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma

NCT05004064 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-04-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Acalabrutinib

Patients will receive acalabrutinib 100mg twice daily for up to six 28 day cycles. Patients can receive 100mg once daily for cycle 1, day 1 to day 7, according to the investigator's discretion.

DRUG

Rituximab

Patient will receive rituximab 375 mg/m2 IV on day 1 (+/- 3 days) of each cycle, for a maximum of 6 cycles

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Principal Investigators

  • Toby Eyre · Churchill Hospital, Oxford, United Kingdom

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2026-11-30
Completion
2028-12-01

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004064 on ClinicalTrials.gov