A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
SOUND-MCL
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
1 other identifier
interventional
55
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2025
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2028
April 8, 2026
April 1, 2026
1.8 years
June 12, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response Rate (ORR)
Investigator-assessed best ORR (CR+PR) as per the Lugano Classification for NHL
From acalabrutinib start to approximately 1 year thereafter
Secondary Outcomes (5)
Time To Response (TTR)
From acalabrutinib start to the first investigator assessed response; up to 30 months since the last subject in
Duration of Response (DoR)
From the time of the first documentation of response to disease progression or death; up to 30 months since the last subject in
Progression-Free Survival (PFS)
From acalabrutinib start to disease progression or death; up to 30 months since the last subject in
Overall Survival (OS)
From acalabrutinib start to death; up to 30 months since the last subject in
Safety and tolerability profile
From enrollment to 30 days after the last dose of acalabrutinib or post-acalabrutinib-treatment disease progression; up to 30 months since the last subject in
Study Arms (1)
Single Arm
EXPERIMENTALAcalabrutinib + R-CHOP standard of care (Induction Phase) plus Acalabrutinib + Rituximab (Maintenance Phase) / Acalabrutinib Monotherapy (Maintenance Phase)
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.
Eligibility Criteria
You may qualify if:
- Adult men or women.
- Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers.
- MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
- Unsuitable for autologous stem cell transplantation.
- Presence of radiologically measurable lymphadenopathy, splenomegaly and/or extranodal lymphoid malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is longest.
- Men must agree to refrain from sperm donation during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is longest.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing tablets without difficulty.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
- WOCBP who are sexually active must use highly effective methods of contraception during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is the longest.
- Male patients should use barrier contraception from the time of screening until 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is longest. Male patients wishing to father children in the future should be advised to arrange for the freezing of sperm prior to the start of study treatment.
You may not qualify if:
- History of prior malignancy except for the following:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
- Adequately treated carcinoma in situ without current evidence of disease.
- Subjects for whom the goal of therapy is tumor debulking before stem cell transplant.
- Subjects who are deemed by the treating physician to be unfit to tolerate the R-CHOP regimen.
- Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).
- Major surgical procedure within 28 days before first dose of study drug.
- Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
- Absolute neutrophil count (ANC) \<1.0 x 109/L or platelet count \<75 x 109/L; for subjects with disease involvement in the bone marrow, ANC \<0.75 x 109/L or platelet count \<50 x 109/L. Subjects will only be considered eligible if peripheral blood counts can be maintained independent of growth factors or transfusions during the screening period.
- Total bilirubin \>1.5 x upper limit normal (ULN) unless other reason known; or aspartate aminotransferase (AST) or alanine transaminase (ALT) \>2.5 x ULN.
- Estimated creatinine clearance of \<30 mL/min, calculated using the formula of Cockcroft and Gault \[(140-age) • mass (kg)/(72 • creatinine mg/dL) • multiply by 0.85 if female\].
- Prothrombin time/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of a lupus anticoagulant) \>2.0 x ULN. Exception: Subjects receiving a vitamin K antagonist are excluded; however, those receiving other anticoagulant therapy who have a higher INR/aPTT may be permitted to enroll to this study after discussion with the medical monitor.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Apices Soluciones S.L.collaborator
Study Sites (22)
Research Site
A Coruña, 15006, Spain
Research Site
Alcorcón, 28922, Spain
Research Site
Badalona, 08916, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Burgos, 09006, Spain
Research Site
Donostia / San Sebastian, 20014, Spain
Research Site
Gijón, 33206, Spain
Research Site
Madrid, 28005, Spain
Research Site
Madrid, 28006, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28029, Spain
Research Site
Majadahonda, 28222, Spain
Research Site
Málaga, 29010, Spain
Research Site
Palma de Mallorca, 07198, Spain
Research Site
Salamanca, 37007, Spain
Research Site
Santa Cruz de Tenerife, 38010, Spain
Research Site
Santander, 39008, Spain
Research Site
Seville, 41013, Spain
Research Site
Valencia, 46010, Spain
Research Site
Valencia, 46017, Spain
Research Site
Vigo, 36214, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2025
First Posted
June 19, 2025
Study Start
September 5, 2025
Primary Completion (Estimated)
June 15, 2027
Study Completion (Estimated)
December 15, 2028
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.