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

Sponsor
GELLC (Grupo Español de Leucemia Linfocítica Crónica)
Study ID
NCT06926205
Phase
PHASE2
Status
Recruiting
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Conditions

  • Richter Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Mosunetuzumab (IV) — DRUG
    6 cycle of Mosunetuzumab+CHOP and then 11 cycles more of mosunetuzumab on mnotherapy

Study Details

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

Key Dates

Start date
May 15, 2024
Status verified
Apr 2025
Primary completion
May 15, 2028
Completion
May 15, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mosunetuzumab
    6 cycle of mosunetuzumab+CHOP and then 11 cycles more of Mosunetuzumab on monotherapy.

Primary Outcome Measure

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. [ Time Frame: During 6 cycles (up to 6 months) ]

Central Contacts

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