Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma

Sponsor
University College, London
Study ID
NCT05004064
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2023
Status verified
Oct 2024
Primary completion
Nov 30, 2026
Completion
Dec 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib and rituximab
    Patients with untreated mantle cell lymphoma will receive acalabrutinib and rituximab for up to six cycles. Each cycle will comprise of acalabrutinib 100mg twice daily orally for 28 days and rituximab 375mg/m2 IV on day 1 (+/1 3 days) of every cycle.

Primary Outcome Measure

Overall response rate [ Time Frame: 24 weeks ]

Central Contacts

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