Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
A Phase 2 Study of Acalabrutinib, Venetoclax and Tafasitamab (AVT) in Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
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)
Incidence of unacceptable toxicity
Time frame: From cycle 1 day 1 to completion of cycle 4 (cycle length = 28 days)
Complete response with undetectable minimal residual disease (MRD)
Time frame: At the end of therapy after a minimum of 4 cycles
Secondary Endpoints
Overall response
Progression free survival
Duration of response
Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * 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/SLL, except steroids and/or rituximab to treat autoimmune complications * Active disease meeting criteria for requiring treatment per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines * A minimum of any one of the following constitutional symptoms: * Unintentional weight loss \> 10% within the previous 6 months…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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