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Monoclonal Antibody
Zanubrutinib + Tafasitamab for Mantle Cell Lymphoma (ZANU-TAFA Trial)
Phase 1 & 2
Waitlist Available
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
ZANU-TAFA Trial 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.Check my eligibility
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.See study design
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.
ZANU-TAFA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is confirmed as mantle cell type by a lab test.
Select...
My scans show active cancer areas that can be measured.
Select...
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.
ZANU-TAFA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Recommended Phase 2 Dose (RP2D) of Zanubrutinib
Phase 2: Rate of Complete Response (CR) to Zanubrutinib at RP2D
Secondary outcome measures
Number of Participants Experiencing Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Overall Response Rate (ORR)
Overall Survival (OS)
+3 moreZANU-TAFA 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:
Early induction - cycles 1 to 3 (12 weeks)
Late induction - cycles 4 to 12 (36 weeks)
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:
Early induction - cycles 1 to 3 (12 weeks)
Late induction - cycles 4 to 12 (36 weeks)
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
~1940
Tafasitamab
2016
Completed Phase 2
~180
Find a Location
Who is running the clinical trial?
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,787 Total Patients Enrolled
MorphoSys AGIndustry Sponsor
26 Previous Clinical Trials
6,633 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,138 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has enrollment for this experimental protocol opened to the public?
"As per the data hosted on clinicaltrials.gov, this particular medical study is not currently enrolling patients. The trial was first posted in November of 2023 and last edited at the end of August that same year. Although this specific research project has ceased recruitment for now, there are over 1700 other trials actively accepting participants."
Answered by AI
What are the projected successes of this trial?
"This medical trial will evaluate the Complete Response (CR) Rate of Zanubrutinib at Recommended Phase 2 Dose (RP2D) over a 4 week period. Secondary outcomes include Progression-free Survival, Overall Survival, as well as the number of participants experiencing Treatment-related Adverse Events and Serious Adverse Events which be noted with National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 guidelines."
Answered by AI
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