CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL
Trial Parameters
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Brief Summary
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
Inclusion Criteria: 1. 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. 2. Aged between 18 and 79 years at the time of signing the Informed Consent Form 3. Ability to comply with the study protocol and procedures and required hospitalizations, in the investigator's judgement. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2. 5. Adult patients with previously untreated, histologically proven Richter's syndrome, diffuse large B cell variants, following WHO 2008 criteria (Swerdlow SH, 2008). 6. Screening flow cytometry or immunohistochemistry (IHC) evidence of CD20 positive disease as per central review (dim expression of CD20 is acceptable) 7. Adequate BM function independent of growth factor or transfusion at screening as follows unless cytopenia is clearly due to marrow involvement of CLL: 1. Platelet count ≥75 x 109/L;