The goal of this clinical trial is to learn if drug Mosunetuzumab works to treat Richter´syndrome . It will also learn about the safety of drug Mosunetuzumab. The main questions it aims to evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction in patients with Richter´s Syndrome who have never received thearapy
What medical problems do participants have when taking drug Mosunetuzumab? Patients with Richter´s Syndrome
Participants will:
Take drug Mosunetuzumab+CHOP during 6 cycle and they if they are not candidate to Alothasplant continuing 11 cycles more with mosunetuzumab on monoterapy Visit the clinic once every 23weeks for checkups and tests
Capable of giving signed informed consent as described in Section 13.2, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and this protocol.
Aged between 18 and 79 years at the time of signing the Informed Consent Form
Ability to comply with the study protocol and procedures and required hospitalizations, in the investigator's judgement.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2.
Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab.
Autologous SCT within 100 days prior to first mosunetuzumab administration.
Allogeneic stem cell transplant for CLL
CAR T-cell therapy for CLL within 100 days before first study treatment
Single group
Mosunetuzumab (IV)
Drug6 cycle of Mosunetuzumab+CHOP and then 11 cycles more of mosunetuzumab on mnotherapy
To evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) in patients with RS who have never received therapy.
Primary endpoint will be complete remission (CR) evaluated by an independent review committee according to modified Lugano classification using PET/CT scan (Cheson et al. 2016) after the EoI visit. CR is defined as a score of 1, 2 or 3 for lymph nodes and extra-lymphatic sites at PET without new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. All PET evaluable in patients with at least one dose of mosunetuzumab will be included in the efficacy population.
To evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) and maintenance (EoM) in patients with therapy naive RS
Evaluated response assesment with CR
To evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) and maintenance (EoM) in patients with therapy naive RS
Evaluated response assesment with PFS.
To evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) and maintenance (EoM) in patients with therapy naive RS
Evaluated response assesment with OS
To evaluate the efficacy of mosunetuzumab combined with CHOP (M-CHOP) after the end of induction (EoI) and maintenance (EoM) in patients with therapy naive RS
Evaluated response assesment with MRD
Biomarkers Objetive: To evaluate the relationship between various screening prognostic markers (clinical and biological) and clinical outcomes
Molecular (IGHV and TP53 status) and genetic prognostic factors (complex karyotype) Clonality MRD response and its relationship with the efficacy outcomes of PFS
Biomarkers Objetive: To evaluate the relationship between various screening prognostic markers (clinical and biological) and clinical outcomes
Molecular (IGHV and TP53 status) and genetic prognostic factors (complex karyotype) Clonality MRD response and its relationship with the efficacy outcomes of OS
Biomarkers Objetives: To assess MRD using several technologies, including ctDNA
Molecular (IGHV and TP53 status) and genetic prognostic factors (complex karyotype) Clonality MRD response and its relationship with the efficacy outcomes of PFS
Biomarkers Objetives: To assess MRD using several technologies, including ctDNA
Molecular (IGHV and TP53 status) and genetic prognostic factors (complex karyotype) Clonality MRD response and its relationship with the efficacy outcomes of OS
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GELLC (Grupo Español de Leucemia Linfocítica Crónica)
Lead sponsor
Evidenze CRO
Collaborator
