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Acalabrutinib plus R-CHOP as first-line treatment for 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

PHASE2 · AstraZeneca · NCT07029737

This test will see if adding acalabrutinib to standard R-CHOP helps adults in Spain with newly diagnosed mantle cell lymphoma.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment55 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsrituximab, acalabrutinib, cyclophosphamide, doxorubicin
Locations22 sites (A Coruña and 21 other locations)
Trial IDNCT07029737 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label Phase 2 trial enrolling about 55 previously untreated adults with mantle cell lymphoma at roughly 20 sites in Spain. Participants receive acalabrutinib 100 mg twice daily together with institution-standard R-CHOP for six induction cycles, followed by acalabrutinib monotherapy until progression; those who achieve at least a partial response also receive maintenance rituximab every other 28-day cycle for up to 12 doses. A safety run-in will be performed for the first six patients older than 75 years, and an early efficacy check will be done after the first ten patients complete induction. The study will track response rates, safety, and duration of disease control with this combination approach.

Who should consider this trial

Good fit: Adults with pathologically confirmed, previously untreated mantle cell lymphoma who require therapy, have measurable disease, are unsuitable for autologous stem cell transplant, and have ECOG performance status 0–2 are the intended participants.

Not a fit: Patients who have already received systemic therapy for MCL, who are candidates for autologous transplant, or who have medical conditions that make BTK inhibitors or R-CHOP unsafe are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase the chance of early tumor response and extend the time patients remain in remission.

How similar studies have performed: BTK inhibitors including acalabrutinib have shown activity in relapsed or refractory MCL, but combining acalabrutinib with frontline R-CHOP is exploratory and supported by limited prior phase II data.

Eligibility criteria

Show full inclusion / exclusion criteria 
INCLUSION CRITERIA:

1. Adult men or women.
2. 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.
3. MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
4. Unsuitable for autologous stem cell transplantation.
5. Presence of radiologically measurable lymphadenopathy, splenomegaly and/or extranodal lymphoid malignancy.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
7. 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.
8. 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.
9. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing tablets without difficulty.
10. 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).
11. 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.
12. 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.

EXCLUSION CRITERIA:

1. History of prior malignancy except for the following:

   1. 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.
   2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.
   3. Adequately treated carcinoma in situ without current evidence of disease.
2. Subjects for whom the goal of therapy is tumor debulking before stem cell transplant.
3. Subjects who are deemed by the treating physician to be unfit to tolerate the R-CHOP regimen.
4. Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.
5. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).
6. Major surgical procedure within 28 days before first dose of study drug.
7. 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.
8. 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.
9. 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.
10. Estimated creatinine clearance of \<30 mL/min, calculated using the formula of Cockcroft and Gault \[(140-age) • mass (kg)/(72 • creatinine mg/dL) • multiply by 0.85 if female\].
11. 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.
12. 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.
13. Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug.
14. Known history of infection with human immunodeficiency virus (HIV).
15. Ongoing immunosuppressive therapy, including systemic corticosteroids within 2 weeks before the first dose of study drug.
16. Known history of anaphylaxis or hypersensitivity to any study drug, or any of their components.
17. Serologic status reflecting active hepatitis B or C infection.

    1. Subjects who are anti-HBc positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result before the first dose of study drug. Those who are HbsAg positive or hepatitis B PCR positive will be excluded.
    2. Subjects who are hepatitis C antibody positive will need to have a negative PCR result before the first dose of study drug. Those who are hepatitis C PCR positive will be excluded.
18. Received a live virus vaccination within 28 days of first dose of study drug.
19. History of stroke or intracranial hemorrhage within 6 months of first dose of study drug.
20. History of bleeding diathesis.
21. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug.
22. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
23. Requires treatment with a strong CYP3A inhibitor/inducer.
24. Concurrent participation in another therapeutic clinical trial.
25. Active cytomegalovirus (CMV) infection (active viremia as evidenced by positive PCR result for CMV DNA).
26. History of confirmed progressive multifocal leukoencephalopathy (PML).
27. Pregnant or breastfeeding women.

Where this trial is running

A Coruña and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Mantle-cell Lymphoma, Acalabrutinib, Previously untreated mantle-cell lymphoma, MCL, R-CHOP

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.