The Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined With Obinutuzumab in MCL (NCT07548255) | Clinical Trial Compass
Not Yet RecruitingPhase 1
The Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined With Obinutuzumab in MCL
China28 participantsStarted 2026-04-20
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Histologically confirmed, previously untreated mantle cell lymphoma (MCL), with at least one of the following high-risk features:
✓. Blastoid or pleomorphic morphology;
✓. Ki-67 ≥30%;
✓. TP53 mutation or deletion;
✓. 17p deletion;
✓. High-risk MIPI group with an expected survival \>3 months.
✓. Laboratory criteria meeting the following requirements:
Exclusion criteria
✕. Contraindications to any of the study drugs.
✕. 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).
✕. Human immunodeficiency virus (HIV) infection.
✕. 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.
✕. Congenital long QT syndrome or QTc \>480 ms (QTc must be calculated using Fridericia's formula: QTcF = QT/(RR)\^0.33).
What they're measuring
1
Complete response rate
Timeframe: At the end of Cycle 6 (each cycle is 28 days)
✕. 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.
✕. 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).
✕. Prior history of significant neurological or psychiatric disorders, or history of psychotropic drug abuse or substance abuse.