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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