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

NCT07029737 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Mantle-cell Lymphoma

Interventions

DRUG

Acalabrutinib + R-CHOP standard of care

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.

DRUG

Acalabrutinib combination with Rituximab

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.

DRUG

Acalabrutinib monotherapy

If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2027-06-15
Completion
2028-12-15

Countries

  • Spain

Study Locations

More Related Trials

Entities

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 NCT07029737 on ClinicalTrials.gov