RecruitingPhase IIEN originalLymphoma

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Dorosłe osoby (mężczyźni i kobiety)
  • Potwierdzony chłoniak Mantla z charakterystyczną zmianą genetyczną t(11;14) lub podwyższonym poziomem cykliny D1
  • Pacjenci, którzy nigdy wcześniej nie otrzymywali żadnego leczenia przeciwnowotworowego
  • Nieskuteczni kandydaci do autologicznego przeszczepienia szpiku kostnego
  • Obecne zmiany nowotworowe widoczne w badaniach obrazowych
  • Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (wg skali ECOG ≤2)
  • Zdolność połykania tabletek bez problemów
  • Chęć uczestnictwa i podpisanie zgody na udział w badaniu

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
130 Years
Last updated (source)
July 10, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (22)

Research Site

A Coruña, Spain

Research Site

Alcorcón, Spain

Research Site

Badalona, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Burgos, Spain

Research Site

Donostia / San Sebastian, Spain

Research Site

Gijón, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Majadahonda, Spain

Research Site

Málaga, Spain

Research Site

Palma de Mallorca, Spain

Research Site

Salamanca, Spain

Research Site

Santa Cruz de Tenerife, Spain

Research Site

Santander, Spain

Research Site

Seville, Spain

Research Site

Valencia, Spain

Research Site

Valencia, Spain

Research Site

Vigo, Spain

Trial contact

AstraZeneca Clinical Study Information Center

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.

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