FILOCLL017 - NEVOTAL : Nemtabrutinib in addition to Venetoclax-Obinutuzumab in chronic lymphocytic leukemia (CLL) / small lymphocytic leukemia (SLL) patients with TP53 ALterations

Condition studied

Patients with previously untreated chronic lymphocytic leukemia (CLL) or / small lymphocytic leukemia (SLL) requiring therapy according to iwCLL 2018 criteria with TP53 abnormalities (either 17p deletion by fluorescence in situ hybridization [FISH] and/or chromosome banding array [CBA] or TP53 mutations).

Investigational medicinal product(s)

Every trial of Nemtabrutinib, Obinutuzumab and Venetoclax across our registers →

Eligibility

Primary endpoint

The primary endpoint is the rate of complete response (CR) / CR with incomplete marrow recovery (CRi), according to iwCLL guidelines, with undetectable minimal residual disease (uMRD), evaluated by flow cytometry at a level of 10-4 in bone marrow (BM) at C16D1 (which corresponds to the completion of 15 cycles of nemtabrutinib, 12 cycles of venetoclax and 6 cycles of obinutuzumab) or at premature discontinuation of all treatments (nemtabrutinib, venetoclax and obinutuzumab).

Endpoint detail

To assess the efficacy of the NVO regimen : • Progression-free survival (PFS) according to iwCLL 2018 criteria; • Best overall response rate (OOR) according to iwCLL 2018 criteria; • Duration of response ; • Bone marrow (BM) undetectable minimal residual disease (uMRD) at a level of 10-4 at C16D1 ; • Overall survival (OS), To determine the safety and toxicity: - hematologic toxicity (Hb, platelets, neutrophils) in CLL participants will be assessed by the grading scale in the iwCLL guidelines ; - - CTCAE v6.0 will be used to grade nonhematological toxicities in CLL participants and all toxicities (hematological and nonhematological) in SLL participants