NCT07029737

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

The SOUND-MCL Study: A Single-arm, Open-label, Multicenter, Phase II Study of Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 the standard of care CIT in Spain, for the front-line treatment of MCL in Spain. Approximately 55 subjects meeting the eligibility criteria for the study will receive acalabrutinib, in combination with R-CHOP for previously untreated MCL, in approximately 20 Spanish sites. Acalabrutinib will be administered 100 mg twice per day (BID) orally (PO) until disease progression if medically appropriate, along with R-CHOP based on institutional standards. A safety run-in will be performed for the first 6 patients older than 75 years included in the study (timeframe: after completing three cycles of the induction phase). A confirmatory assessment of sufficient efficacy for the acalabrutinib + R-CHOP regimen will be performed for the first 10 patients treated with acalabrutinib + R-CHOP (timeframe: after completing six induction cycles). After 6 cycles of acalabrutinib in combination with R-CHOP, subjects who tolerate treatment and not progressing, will then receive monotherapy acalabrutinib 100 mg BID. In addition, subjects who achieve a response (PR or greater) will receive maintenance rituximab 375 mg/m2 on Day 1 of every other 28-day cycle for a maximum of 12 additional doses. Thereafter, subjects will receive monotherapy acalabrutinib 100 mg BID (or last tolerated dose) until disease progression or treatment discontinuation for any reason. The planned duration of recruitment is approximately 12 months. Data will be collected since the inclusion of the first subject, with a maximum prospective follow-up of 30 months since the last subject in. Each subject will be followed up from screening, until the withdrawal from the study, lost to follow-up, death or the end of the study (i.e., 30 months since the last patient in), whichever occurs first.

Conditions

• Mantle-cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-05
• Primary completion: 2027-06-15
• Completion: 2028-12-15
• First posted: 2025-06-19
• Last updated: 2026-04-08

Locations

22 sites across 1 country: Spain