CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorGELLC (Grupo Español de Leucemia Linfocítica Crónica)

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Mosunetuzumab (IV)

Treatment groups

34 Participants
are divided into 1 treatment group

Sponsors and collaborators