Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study
A Phase 2 Study With a Safety Lead-In of the Anti-CD19 Antibody Tafasitamab With the BTK Inhibitor Zanubrutinib in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - TaZa CLL Study
Sponsor: City of Hope Medical Center + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Complete response (CR) rate
Time frame: Up to 5 years
Incidence of adverse events
Time frame: Up to 5 years
Secondary Endpoints
Overall response rate (ORR)
Progression-free survival (PFS)
Duration of response (DOR)
Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: \>= 18 years * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Histologically or flow cytometry confirmed diagnosis of B-CLL/SLL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO) * No prior treatment for CLL, except steroids and/or rituximab to treat autoimmune complications * Active disease meeting criteria for requiring treatment per the iwCLL 2018 guidelines * A minimum of any one of the following constitutional symptoms: * Unintentional weight loss \> 10% within the previous 6 months prior to screening * Extreme fatigue (unable to work or perform usual activities) * Fevers of greater than 100.5 degrees Fahrenheit (F) for \>= 2 weeks without evidence of infection * Night sweats without evidence of in…
Read full criteria on CT.gov →✦ Analyst Commentary
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