Mantle-cell LymphomaPhase 2SOUND-MCLNCT07029737
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
A Phase 2 study testing Acalabrutinib combination with Rituximab and Acalabrutinib monotherapy in people with Mantle-cell Lymphoma, run by AstraZeneca at 22 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Mantle-cell Lymphoma
- What is being tested?
- Acalabrutinib combination with Rituximab and Acalabrutinib monotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 22 sitesSpain
- Study dates
- 5 Sep 2025to 30 Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 32Show fewer
- 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.
- 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.
- Known history of infection with human immunodeficiency virus (HIV).
- Ongoing immunosuppressive therapy, including systemic corticosteroids within 2 weeks before the first dose of study drug.
- Known history of anaphylaxis or hypersensitivity to any study drug, or any of their components.
- Serologic status reflecting active hepatitis B or C infection.
- 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.
- 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.
- Received a live virus vaccination within 28 days of first dose of study drug.
- History of stroke or intracranial hemorrhage within 6 months of first dose of study drug.
- History of bleeding diathesis.
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
- Requires treatment with a strong CYP3A inhibitor/inducer.
- Concurrent participation in another therapeutic clinical trial.
- Active cytomegalovirus (CMV) infection (active viremia as evidenced by positive PCR result for CMV DNA).
- History of confirmed progressive multifocal leukoencephalopathy (PML).
- Pregnant or breastfeeding women.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
22 sites in 1 country
Spain22 sites, 21 recruiting
- Recruiting
Research Site
A Coruña, 15006
- Recruiting
Research Site
Alcorcón, 28922
- Recruiting
Research Site
Badalona, 08916
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Barcelona, 08036
- Recruiting
Research Site
Burgos, 09006
- Recruiting
Research Site
Donostia / San Sebastian, 20014
- Recruiting
Research Site
Gijón, 33206
- Recruiting
Research Site
Madrid, 28005
- Recruiting
Research Site
Madrid, 28006
- Recruiting
Research Site
Madrid, 28007
- Recruiting
Research Site
Madrid, 28029
- Withdrawn
Research Site
Majadahonda, 28222
- Recruiting
Research Site
Málaga, 29010
- Recruiting
Research Site
Palma de Mallorca, 07198
- Recruiting
Research Site
Salamanca, 37007
- Recruiting
Research Site
Santa Cruz de Tenerife, 38010
- Recruiting
Research Site
Santander, 39008
- Recruiting
Research Site
Seville, 41013
- Recruiting
Research Site
Valencia, 46010
- Recruiting
Research Site
Valencia, 46017
- Recruiting
Research Site
Vigo, 36214
About this study
Official title: 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
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.
Read the detailed description
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 the standard of care CIT in Spain, for the front-line treatment of MCL in Spain.
Approximately 55 subjects meeting the eligibility criteria for the study will receive acalabrutinib, in combination with R-CHOP for previously untreated MCL, in approximately 20 Spanish sites.
Acalabrutinib will be administered 100 mg twice per day (BID) orally (PO) until disease progression if medically appropriate, along with R-CHOP based on institutional standards.
A safety run-in will be performed for the first 6 patients older than 75 years included in the study (timeframe: after completing three cycles of the induction phase).
A confirmatory assessment of sufficient efficacy for the acalabrutinib + R-CHOP regimen will be performed for the first 10 patients treated with acalabrutinib + R-CHOP (timeframe: after completing six induction cycles).
After 6 cycles of acalabrutinib in combination with R-CHOP, subjects who tolerate treatment and not progressing, will then receive monotherapy acalabrutinib 100 mg BID. In addition, subjects who achieve a response (PR or greater) will receive maintenance rituximab 375 mg/m2 on Day 1 of every other 28-day cycle for a maximum of 12 additional doses. Thereafter, subjects will receive monotherapy acalabrutinib 100 mg BID (or last tolerated dose) until disease progression or treatment discontinuation for any reason.
The planned duration of recruitment is approximately 12 months. Data will be collected since the inclusion of the first subject, with a maximum prospective follow-up of 30 months since the last subject in. Each subject will be followed up from screening, until the withdrawal from the study, lost to follow-up, death or the end of the study (i.e., 30 months since the last patient in), whichever occurs first.
- Conditions
- Mantle-cell Lymphoma
- Being tested
- Acalabrutinib + R-CHOP standard of care, Acalabrutinib combination with Rituximab, Acalabrutinib monotherapy
- Keywords
- Acalabrutinib, Previously untreated mantle-cell lymphoma, MCL, R-CHOP
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acalabrutinib + R-CHOP standard of careDrug
Also called Induction Phase
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.
Acalabrutinib combination with RituximabDrug
Also called Maintenance 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.
Acalabrutinib monotherapyDrug
Also called Maintenance Phase
If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Acalabrutinib + R-CHOP standard of care (Induction Phase) plus Acalabrutinib + Rituximab (Maintenance Phase) / Acalabrutinib Monotherapy (Maintenance Phase) Receives: Drug: Acalabrutinib + R-CHOP standard of care; Drug: Acalabrutinib combination with Rituximab; Drug: Acalabrutinib monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate (ORR)
Investigator-assessed best ORR (CR+PR) as per the Lugano Classification for NHL
Measured: From acalabrutinib start to approximately 1 year thereafter
Secondary outcomes (5)
Time To Response (TTR)
TTR, defined as the time from the date of acalabrutinib start to the first investigator-assessed CR or PR per the Lugano Classification for NHL. Measure of interest: median TTR.
Measured: From acalabrutinib start to the first investigator assessed response; up to 30 months since the last subject in
Duration of Response (DoR)
DoR, defined as the time from the first documentation of investigator-assessed CR or PR to disease progression per the Lugano Classification for NHL or death from any cause in the absence of disease progression. Measure of interest: 30-month DoR.
Measured: 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)
PFS, defined as the time from the date of acalabrutinib start to investigator-assessed disease progression as per the Lugano Classification for NHL or death from any cause, whichever occurs first. Measure of interest: 30-month PFS.
Measured: From acalabrutinib start to disease progression or death; up to 30 months since the last subject in
Overall Survival (OS)
OS, defined as the time from the date of acalabrutinib start to the date of death from any cause. Measure of interest: 30-month OS.
Measured: From acalabrutinib start to death; up to 30 months since the last subject in
Safety and tolerability profile
Number and percentage of patients with each MedDRA coded and CTCAE graded adverse (AEs) and serious adverse events (SAEs).
Incidence of AEs of clinical interest for acalabrutinib. Incidence of grade ≥3 AEs. Incidence of AEs leading to acalabrutinib dose modification, temporary interruption or permanent discontinuation.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start5 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle-cell LymphomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029737
- Sponsor's protocol ID
- D8220L00087
- Acronym
- SOUND-MCL
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.