Sonrotoclax + Zanubrutinib for Mantle Cell Lymphoma

Birmingham, AL

Phase 3

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)

* Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 92 months

Awards & highlights

Pivotal Trial

Summary

"This trial aims to see if adding sonrotoclax to zanubrutinib is more effective in treating relapsed/refractory mantle cell lymphoma compared to just using zanubrut

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Who is the study for?

This trial is for adults with mantle cell lymphoma (MCL) who have tried 1-5 treatments including immunotherapy or chemoimmunotherapy and whose disease has come back or didn't respond. They must have a measurable size of cancer, be able to do some daily activities on their own, and have organs that are working well.Check my eligibility

What is being tested?

The study compares the effectiveness and safety of two combinations: Sonrotoclax plus Zanubrutinib versus Zanubrutinib with a placebo in treating MCL that has returned after treatment or hasn't responded to previous treatments.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, liver issues, fatigue, nausea, diarrhea, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis of mantle cell lymphoma is confirmed by the latest WHO or ICC standards.

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I have a tumor larger than 1.5 cm in my lymph nodes or larger than 1 cm elsewhere.

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I am able to get out of bed or chair and move around.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 92 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 92 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 92 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)

Secondary study objectives

Complete Response Rate (CRR) as assessed by BIRC and by INV

Duration of Response (DOR) as assessed by BIRC and by INV

Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

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