The Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined With Obinutuzumab in MCL

April 21, 2026 updated by: Zhao Weili, Ruijin Hospital

A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax and Zanubrutinib Combined With Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma

A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Shanghai Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Age ≥18 years.

  2. Histologically confirmed, previously untreated mantle cell lymphoma (MCL), with at least one of the following high-risk features:

    1. Blastoid or pleomorphic morphology;
    2. Ki-67 ≥30%;
    3. TP53 mutation or deletion;
    4. 17p deletion;
    5. High-risk MIPI group with an expected survival >3 months.

  3. Laboratory criteria meeting the following requirements:

    1. Absolute neutrophil count ≥1,000/mm³ or ≥1.0 × 10⁹/L, platelet count ≥50,000/mm³ or ≥50 × 10⁹/L, and hemoglobin ≥8 g/dL;
    2. Creatinine clearance ≥50 mL/min (calculated using the standard Cockcroft-Gault formula);
    3. Serum albumin ≥3.0 g/dL; total bilirubin ≤1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5.0 × ULN in cases of hepatic lymphoma involvement; serum amylase or lipase ≤ULN;
    4. International normalized ratio (INR) ≤1.5 × ULN or activated partial thromboplastin time (aPTT) ≤1.5 × ULN; for patients receiving warfarin anticoagulation therapy, INR may be between 2 and 3;
    5. Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.

Exclusion Criteria

  1. Contraindications to any of the study drugs.
  2. Known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis (hepatitis B defined as positive hepatitis B core antibody [HBcAb] with HBV-DNA above the ULN; active hepatitis C defined as positive HCV antibody-patients with negative HCV-RNA may be enrolled).
  3. Human immunodeficiency virus (HIV) infection.
  4. Congestive heart failure (New York Heart Association [NYHA] Class >2); history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to enrollment.
  5. Congenital long QT syndrome or QTc >480 ms (QTc must be calculated using Fridericia's formula: QTcF = QT/(RR)^0.33).
  6. History of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, carcinoma in situ of the breast, or other second primary malignancies that were curatively treated and have had no recurrence within 5 years.
  7. Pregnant or breastfeeding women, or those planning to become pregnant during the study period (fertile men and women must agree to use effective contraception during the study and for 30 days after the last dose of study treatment, such as dual-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. Postmenopausal women and surgically sterilized women are exempt).
  8. Prior history of significant neurological or psychiatric disorders, or history of psychotropic drug abuse or substance abuse.
  9. Clinically significant active infection.
  10. Inability to take oral medications, difficulty swallowing, chronic diarrhea, intestinal obstruction, or other conditions that may affect drug administration or absorption.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sonrotoclax, Zanubrutinib Combined with Obinutuzumab treatment
Drug: Sonrotoclax, Zanubrutinib Combined with Obinutuzumab
The treatment regimen was as follows: In cycle 1 (C1), obinutuzumab 1000 mg was administered intravenously on day 1 (D1); sotoroclax was given at 80 mg on D2, 160 mg on D3, and 320 mg on D4; zanubrutinib was administered at 160 mg twice daily (BID). Each cycle was defined as 28 days. From cycles 2 to 6 (C2-C6), patients received obinutuzumab 1000 mg intravenously on D1, sotoroclax 320 mg once daily, and zanubrutinib 160 mg BID.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
The percentage of participants with a complete response at the end of Cycle 6 was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
At the end of Cycle 6 (each cycle is 28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years after enrollment
Overall survival (OS) was measured from the date of diagnosis to the date of death or the last follow-up.
2 years after enrollment
Overall response rate
Time Frame: Overall Response Rate At the end of Cycle 6 (each cycle is 28 days)
The percentage of participants with overall response was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
Overall Response Rate At the end of Cycle 6 (each cycle is 28 days)
Progression free survival
Time Frame: 2 years after enrollment
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
2 years after enrollment
Treatment-Related Adverse Events
Time Frame: From enrollment to study completion, a maximum of 3 years.
An adverse event is any untoward medical occurrence in a participant receiving a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease that is temporally associated with the use of a pharmaceutical product, whether or not it is considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
From enrollment to study completion, a maximum of 3 years.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma circulating tumor DNA (ctDNA) levels
Time Frame: From enrollment to study completion, a maximum of 3 years
Exploratory biomarker of ctDNA to predict treatment response and survival
From enrollment to study completion, a maximum of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Solide

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intermediate-to-High-Risk Mantle Cell Lymphoma

Clinical Trials on Sonrotoclax, Zanubrutinib Combined with Obinutuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings