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Monoclonal Antibody

Zanubrutinib + Tafasitamab for Mantle Cell Lymphoma (ZANU-TAFA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Alvaro Alencar, MD

Eligibility Criteria Checklist

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

Must have

Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification

Baseline PET/CT scans must demonstrate fluorodeoxyglucose (FDG) avid lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the best dose and effectiveness of combining two drugs to treat mantle cell lymphoma.

Who is the study for?

This trial is for adults over 18 with mantle cell lymphoma confirmed by WHO criteria, who have a life expectancy of more than 4 months and normal organ/marrow function. They must have at least one measurable disease site and be willing to avoid pregnancy or fathering children during the study.

What is being tested?

The trial aims to determine the optimal dose of Zanubrutinib combined with Tafasitamab in treating mantle cell lymphoma. It also evaluates how effective this combination therapy is for patients with this condition.

What are the potential side effects?

Potential side effects from Zanubrutinib and Tafasitamab may include reactions at the infusion site, changes in blood counts leading to increased infection risk, liver issues, fatigue, and other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is confirmed as mantle cell type by a lab test.

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My scans show active cancer areas that can be measured.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 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

Phase 1: Recommended Phase 2 Dose (RP2D) of Zanubrutinib

Phase 2: Rate of Complete Response (CR) to Zanubrutinib at RP2D

Secondary study objectives

Number of Participants Experiencing Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

Overall Response Rate (ORR)

Overall Survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Zanu-Tafa Phase 2 GroupExperimental Treatment2 Interventions

Participants in this group will receive the combination therapy of Zanubrutinib (Zanu) at the recommended phase 2 dose (RP2D) determined during Phase 1, and Tafasitamab at standard doses, followed by maintenance therapy with Zanubrutinib until progression.. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years.

Group II: Zanu-Tafa Phase 1 GroupExperimental Treatment2 Interventions

Participants in this group will receive combination therapy of Zanubrutinib (Zanu) and Tafasitamab (Tafa) for up to 24 cycles, followed by maintenance therapy with Zanubrutinib until progression. Each cycle is 28 days in length. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zanubrutinib

2017

Completed Phase 3

~2160

Tafasitamab

2016

Completed Phase 3

~630