A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain

Sponsor
AstraZeneca
Study ID
NCT07029737
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib + R-CHOP standard of care — DRUG
    Acalabrutinib will be administered 100 mg twice per day (BID) orally (PO) until disease progression if medically appropriate, along with R-CHOP standard of care up to six 21-day cycles of the induction phase.
  • Acalabrutinib combination with Rituximab — DRUG
    If the subject achieves response during the induction phase, acalabrutinib will be administered 100 mg BID PO until disease progression and rituximab 375 mg/m2 on Day 1 of every other 28-day cycle for a maximum of 12 additional doses.
  • Acalabrutinib monotherapy — DRUG
    If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression.

Study Details

This is a single-arm, open-label, multicenter, non-indication seeking phase II trial to describe the efficacy and safety of patients with mantle cell lymphoma (MCL) receiving acalabrutinib in combination with R-CHOP for the front-line treatment of MCL in Spain. Acalabrutinib will be administered until disease progression if medically appropriate, along with R-CHOP based on institutional standards. After 6 cycles of acalabrutinib in combination with R-CHOP, subjects who tolerate treatment and not progressing, will then receive monotherapy acalabrutinib. In addition, subjects who achieve a response (PR or greater) will receive maintenance rituximab every other 28-day cycle for a maximum of 12 additional doses. Thereafter, subjects receive monotherapy acalabrutinib until disease progression or treatment discontinuation.

Key Dates

Start date
Sep 5, 2025
Status verified
Jun 2026
Primary completion
Jun 15, 2027
Completion
Dec 15, 2028

Study Design

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

Arms

  • Experimental: Single Arm
    Acalabrutinib + R-CHOP standard of care (Induction Phase) plus Acalabrutinib + Rituximab (Maintenance Phase) / Acalabrutinib Monotherapy (Maintenance Phase)

Primary Outcome Measure

Best Overall Response Rate (ORR) [ Time Frame: From acalabrutinib start to approximately 1 year thereafter ]

Central Contacts

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