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
AstraZeneca
55 participants
Sep 5, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
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.
If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression.
Locations(22)
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NCT07029737