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Monoclonal Antibodies
Tafasitamab + Zanubrutinib for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Matthew Mei
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests if two drugs together can help treat CLL/SLL. One drug stops cancer cells from multiplying, the other stops cancer cell growth and spread. Together, they may kill more cancer cells.
Who is the study for?
Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment and can swallow pills. They should have no prior CLL treatments (except certain steroids/rituximab), stable organ function, and no severe bleeding disorders or liver disease. Participants must agree to use birth control and not be pregnant.Check my eligibility
What is being tested?
The trial is testing the combination of tafasitamab, a monoclonal antibody, and zanubrutinib, a kinase inhibitor protein blocker, in treating newly diagnosed patients. It aims to see if this combo is more effective than individual treatments for stopping cancer cell growth.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs, issues from bone marrow biopsies like pain or bleeding, liver problems due to medication interactions, fatigue from anemia caused by chemotherapy agents used in treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR) rate
Incidence of adverse events
Secondary outcome measures
Duration of response (DOR)
Overall response rate (ORR)
Progression-free survival (PFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tafasitamab and zanubrutinib)Experimental Treatment5 Interventions
Patients receive tafasitamab IV and zanubrutinib PO on study. Patients also undergo collection of blood samples on study and undergo CT scan and bone marrow biopsy throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Zanubrutinib
2017
Completed Phase 3
~1940
Tafasitamab
2016
Completed Phase 2
~180
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,635 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,416 Total Patients Enrolled
Matthew MeiPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys work well enough, with a clearance rate of at least 30 mL/min.My blood clotting measurements are within safe limits, with or without anticoagulants.I can perform all my self-care activities and am up more than 50% of my waking hours.I am 18 years old or older.I have not had major surgery in the last 30 days.I take more than 20 mg/day of prednisone or its equivalent.I have CLL and only received steroids or rituximab for autoimmune issues.I have stopped using strong CYP3A inhibitors at least 2 weeks before starting the study.I can swallow pills without any issues.I have not had a live vaccine in the last 30 days and do not plan to get one during treatment.I haven't taken strong medication that affects liver enzymes in the last 2 weeks.My platelet count is at least 75,000/mm^3 without transfusions and I have no active bleeding.My blood clotting time is normal or managed if I'm on blood thinners.My white blood cell count is healthy, not due to bone marrow issues.My condition requires treatment according to the latest CLL guidelines.I do not have uncontrolled bleeding disorders but I am on oral anticoagulants.I have experienced significant weight loss, extreme fatigue, fevers, night sweats, or other specific symptoms without infection.My medical records confirm I have B-CLL/SLL as per WHO criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tafasitamab and zanubrutinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research open to the public at present?
"Clinicaltrials.gov has reported that the initial posting of this medical trial on July 15th 2023 is not currently seeking to enrol patients. However, at present there are 2817 other clinical trials recruiting participants as an alternative option."
Answered by AI
Has the FDA officially sanctioned tafasitamab and zanubrutinib as viable treatments?
"Our team at Power assigned Treatment (tafasitamab and zanubrutinib) a score of 2 due to its Phase 2 status, as it has some evidence pointing towards safety yet no data regarding efficacy."
Answered by AI
What primary goals are sought by this experiment?
"The primary monitoring metric for this study is the rate of adverse events, which will be recorded and analyzed over a period up to 5 years. Secondary outcomes include Progression-free Survival (PFS), Duration of Response (DOR) and Undetectable Minimal Residual Disease Rate (uMRD). All metrics are estimated using the Kaplan-Meier product limit method with Greenwood confidence intervals constructed via log-log transformation. Median values will also be ascertained when available."
Answered by AI
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