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Bruton's Tyrosine Kinase (BTK) Inhibitor

Induction therapy (Zanubrutinib, rituximab) 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) 1 (Arm A)

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

Secondary outcome measures

Complete response rate (CR)

Event-free survival (EFS) 1

Event-free survival (EFS) 2

+3 more

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

~980

Biospecimen Collection

2004

Completed Phase 2

~1700

Positron Emission Tomography

2008

Completed Phase 2

~2240

Zanubrutinib

2017

Completed Phase 3

~1940

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Colonoscopy

2012

Completed Phase 3

~115560

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Computed Tomography

2017

Completed Phase 2

~2720

Rituximab

1999

Completed Phase 4

~1880

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,217 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,020 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the geographical scope of this research endeavor?

"At the time of writing, this trial is recruiting at 62 sites. Locations include Pekin, Dixon and Duarte among others. It may be beneficial to select a nearby site in order to minimize any travel burden associated with enrollment."

Answered by AI

Is there currently opportunity for participation in this clinical experiment?

"The clinical trial is currently enlisting patients, as evidenced by its postings on clinicaltrials.gov which date back to September 8th 2023 and was recently updated November 30th of the same year."

Answered by AI

How many individuals are being granted access to this experimental research?

"Correct. As indicated on clinicaltrials.gov, the trial is currently seeking 421 patients among 62 different medical sites. This experiment was first advertised on September 8th 2023 and its details were recently updated at the end of November that same year."

Answered by AI

Does the FDA recognize induction therapy (Zanubrutinib, rituximab) as a viable treatment option?

"Based on existing safety data, our team at Power ascribed a score of 3 to the induction therapy (Zanubrutinib, rituximab) being trialled. This is because it has reached Phase 3 and boasts evidence of efficacy as well as multiple studies confirming its security profile."

Answered by AI

What would constitute a successful outcome for this experiment?

"The core objective of this trial is to measure Progression-Free Survival (PFS 2) in Arm B from randomisation until the earlier of first progression or death. Additional secondary outcomes encompass Event Free Survival (EFS2), Adverse Events, and Overall Response Rate (ORR). ORR will be assessed using Lugano criteria with frequencies and rates summarised by treatment arm. Statistical methods such as Kaplan-Meier methodology, Cox Proportional Hazards models, Chi-squared tests, Fisher's Exact test etc., shall be employed for evaluation purposes. Additionally, Tolerability metrics like dose delays/modifications &"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

2023. "Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05976763.

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