Actively Recruiting
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
Led by AstraZeneca · Updated on 2026-05-07
55
Participants Needed
22
Research Sites
171 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
A
Apices Soluciones S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women
- Pathologically confirmed mantle cell lymphoma with specific genetic markers
- Requires treatment with no prior systemic anticancer therapies
- Not suitable for autologous stem cell transplantation
- Presence of measurable lymphadenopathy, splenomegaly, or extranodal lymphoid malignancy
- ECOG performance status of 2 or less
- Sexually active men must agree to use effective contraception during and after study treatment
- Men must refrain from sperm donation during and after treatment
- Willing and able to participate in all required study evaluations and able to swallow tablets
- Ability to understand study purpose and provide informed consent
- Sexually active women of childbearing potential must use effective contraception during and after treatment
- Male patients should use barrier contraception and consider sperm banking before treatment
You will not qualify if you...
- History of prior malignancy except certain treated cancers with no active disease for over 2 years
- Intended tumor debulking before stem cell transplant
- Unfit to tolerate R-CHOP chemotherapy
- History of central nervous system lymphoma or leptomeningeal disease
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Major surgery within 28 days before first dose
- Significant cardiovascular disease or recent heart events
- Low neutrophil or platelet counts unless stable without growth factors or transfusions
- Elevated liver enzymes or bilirubin beyond defined limits
- Severe kidney impairment
- Abnormal clotting times unless on certain anticoagulants
- Gastrointestinal conditions affecting drug absorption or surgery
- Active uncontrolled infections or recent intravenous anti-infective treatment
- Known HIV infection
- Recent immunosuppressive therapy including systemic corticosteroids
- Known allergies to study drugs or components
- Active hepatitis B or C infection
- Recent live virus vaccination
- Recent stroke or intracranial hemorrhage
- History of bleeding disorders
- Recent gastrointestinal ulcer
- Use of warfarin or vitamin K antagonists
- Treatment with strong CYP3A inhibitors or inducers
- Participation in another therapeutic clinical trial
- Active cytomegalovirus infection
- History of progressive multifocal leukoencephalopathy
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Research Site
A Coruña, Spain, 15006
Actively Recruiting
2
Research Site
Alcorcón, Spain, 28922
Actively Recruiting
3
Research Site
Badalona, Spain, 08916
Actively Recruiting
4
Research Site
Barcelona, Spain, 08035
Actively Recruiting
5
Research Site
Barcelona, Spain, 08036
Actively Recruiting
6
Research Site
Burgos, Spain, 09006
Actively Recruiting
7
Research Site
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
8
Research Site
Gijón, Spain, 33206
Actively Recruiting
9
Research Site
Madrid, Spain, 28005
Actively Recruiting
10
Research Site
Madrid, Spain, 28006
Actively Recruiting
11
Research Site
Madrid, Spain, 28007
Actively Recruiting
12
Research Site
Madrid, Spain, 28029
Actively Recruiting
13
Research Site
Majadahonda, Spain, 28222
Withdrawn
14
Research Site
Málaga, Spain, 29010
Actively Recruiting
15
Research Site
Palma de Mallorca, Spain, 07198
Actively Recruiting
16
Research Site
Salamanca, Spain, 37007
Actively Recruiting
17
Research Site
Santa Cruz de Tenerife, Spain, 38010
Actively Recruiting
18
Research Site
Santander, Spain, 39008
Actively Recruiting
19
Research Site
Seville, Spain, 41013
Actively Recruiting
20
Research Site
Valencia, Spain, 46010
Actively Recruiting
21
Research Site
Valencia, Spain, 46017
Actively Recruiting
22
Research Site
Vigo, Spain, 36214
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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