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Bruton's Tyrosine Kinase (BTK) Inhibitor

Zanubrutinib for Mantle Cell Lymphoma

Phase 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody

Age >= 70 years OR age >= 60 to < 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) < 45%, b) diffusing capacity for carbon monoxide < 60% predicted; c) creatinine clearance < 70 but > 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score > 6

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests whether stopping & restarting zanubrutinib after achieving a CR with rituximab is safe & effective in older MCL patients.

Who is the study for?

This trial is for older adults with untreated Mantle Cell Lymphoma (MCL). Eligible participants are those aged 70+ or 60-69 with certain health issues, have measurable disease, and haven't had prior MCL treatments like stem cell transplants, radiation for stage I MCL, systemic treatments, BTK inhibitors or anti-CD20 monoclonal antibodies.

What is being tested?

The study tests continuous versus intermittent Zanubrutinib treatment after complete remission using Rituximab in older patients with MCL. It aims to determine if stopping Zanubrutinib after remission and restarting upon progression is as effective as continuous treatment.

What are the potential side effects?

Zanubrutinib may cause side effects such as bleeding problems, high blood pressure, infections due to low white blood cell counts, irregular heart rhythm among others. Rituximab can lead to infusion reactions and infections.

Eligibility Criteria

Inclusion Criteria

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

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I have never been treated with BTK inhibitors or anti-CD20 drugs.

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I am over 70 or have health issues that prevent me from undergoing a specific stem cell transplant.

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My lymphoma is confirmed to be mantle cell type with specific genetic markers.

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I have not had a stem cell transplant.

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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 have not had radiation for stage I mantle cell lymphoma.

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I have not received any systemic treatment for mantle cell lymphoma.

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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years 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) 1 (Arm A)

Progression-free survival (PFS) 2 (Arm B)

Secondary study objectives

Complete response rate (CR)

Event-free survival (EFS) 1

Event-free survival (EFS) 2

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Induction therapy (Zanubrutinib, rituximab)Experimental Treatment12 Interventions

Patients receive zanubrutinib PO and rituximab IV on study. Patients undergo bone marrow biopsy and FDG PET/CT or CT throughout the trial. Patients may also undergo EDG and/or colonoscopy on study as clinically indicated. Patients may optionally undergo blood sample collection throughout the trial.

Group II: Arm A (Zanubrutinib)Experimental Treatment11 Interventions

Patients receive zanubrutinib PO until first disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.

Group III: ARM B (Observation)Active Control11 Interventions

Patients undergo observation until first disease progression and then receive zanubrutinib PO until second disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Esophagogastroduodenoscopy

2017

Completed Phase 3

~1240

Biospecimen Collection

2004

Completed Phase 3

~2020