Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
A Phase Ib Study Evaluating the Safety and Efficacy of Tafasitamab, Acalabrutinib, and Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Sponsor: OHSU Knight Cancer Institute + Oregon Health and Science University, Incyte Corporation
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of dose limiting toxicities (DLTs)
Time frame: From first dose of tafasitamab (cycle 2, day 1) to end of cycle 6 (C6D28) up to 2 years. (cycle length = 28 days)
Proportion of patients that achieve minimal residual disease (MRD) negativity in peripheral blood
Time frame: From first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib up to 2 years.(cycle length = 28 days)
Secondary Endpoints
Objective response rate (ORR)
Eligibility Criteria
Participant Inclusion Criteria * Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions * Age \>= 18 years. All genders, races, and ethnic groups will be included * Ability to swallow and retain oral medication * Documented previously untreated CLL/SLL. Diagnosis must be confirmed by peripheral blood flow cytometry or lymph node biopsy and made in accordance with international workshop (iw)CLL diagnostic criteria * Baseline detectable immunoglobulin heavy (IGH) gene signature determined as part of clonoSEQ for minimal residual disease (MRD) testing * Must meet at least 1 criterion for treatment based on iwCLL guidelines * Evidence of progressive marrow failure as manifested by the onset or worsening of anemia and/or thrombocytopenia, or * Massive (i.e., lower edge of spleen \>= 6 cm below the left costal margin), progressive, or symptomatic splenomegaly, or * …
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