Richter SyndromePhase 2GELLC9RICHTERNCT06926205
CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL
A Phase 2 study testing Mosunetuzumab (IV) in people with Richter Syndrome, run by GELLC (Grupo Español de Leucemia Linfocítica Crónica) at 16 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Richter Syndrome
- What is being tested?
- Mosunetuzumab (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 16 sitesSpain
- Study dates
- 15 May 2024to 15 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Adult patients with previously untreated, histologically proven Richter's syndrome, diffuse large B cell variants, following WHO 2008 criteria (Swerdlow SH, 2008).
- Screening flow cytometry or immunohistochemistry (IHC) evidence of CD20 positive disease as per central review (dim expression of CD20 is acceptable)
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- Adequate BM function independent of growth factor or transfusion at screening as follows unless cytopenia is clearly due to marrow involvement of CLL:
- Platelet count ≥75 x 109/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), platelet count should be ≥ 30 x 109/L.
- ANC ≥1 x 109/L unless neutropenia is clearly due to marrow involvement of CLL (per the discretion of the investigator)
- Total hemoglobin ≥ 9 g/dL unless anemia is due to marrow involvement of CLL (per the discretion of the investigator)
- Measured or estimated creatinine clearance ≥ 45 mL/min by institutional standard method.
- Life expectancy > 3 months
- For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year, and agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable).
- It is recommended to remain abstinent or use contraception for 12 months after the final dose of cyclophosphamide, doxorubicin, or vincristine.
- A woman is considered to be of childbearing potential (WOCBP) if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
- If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the Informed Consent Form.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
- With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 60 days after the final dose of tocilizumab (if applicable) and must remain abstinent or use a condom for 12 months after the final dose of cyclophosphamide, doxorubicin, or vincristine to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing drug exposure. If required per local guidelines or regulations, information about the reliability of abstinence will be described in the Informed Consent Form.
Who cannot join
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab.
- WOCBP must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. If a serum pregnancy test has not been performed within 14 days prior to receiving first study treatment, a negative urine pregnancy test result (performed within 7 days prior to study treatment) must be available.
- Participants who have received any of the following treatments prior to study entry:
- Treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies.
- Participants who have received any of the following treatments, whether investigational or approved, given to treat RS, within the respective time periods prior to initiation of study treatment:
- Autologous SCT within 100 days prior to first mosunetuzumab administration.
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- Allogeneic stem cell transplant for CLL
- CAR T-cell therapy for CLL within 100 days before first study treatment
- Systemic corticosteroid treatment ≤ 20 mg/day prednisone or equivalent to control symptoms related to disease progression for a maximum of 5 days before starting C1D1 and inhaled corticosteroids are permitted.
- Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
- Transformation of CLL to prolymphocytic leukemia.
- History of prior malignancy, except for conditions as listed below if patients have recovered from the acute side effects incurred as a result of previous therapy:
- Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Surgically/adequately treated low grade, early stage, localized prostate cancer without evidence of disease.
- Any of the following laboratory abnormalities:
- Calculated creatinine Clearance < 45 mL/min (by institutional standard method.).
- Absolute neutrophil count (ANC) < 1.0 x 109/L, unless secondary to bone marrow involvement by CLL.
- Platelet count <75 x 109/L except if thrombocytopenia is clearly due to marrow involvement of CLL (per the discretion of the investigator) for which exclusion criteria would be platelet count < 30 x 109/L.
- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetictransaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >2.5 x upper limit of normal (ULN).
- Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's syndrome.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- Contraindication to tocilizumab.
- Presence of any autoimmune disorder including autoimmune hemolytic anemia or autoimmune thrombocytopenia active at the moment of first dose of therapy.
- Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible.
- History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Exceptions include the following:
- Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
- Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Coordinators.
- History of solid organ transplantation
- Participants with infections requiring IV treatment with antibiotics or hospitalization (Grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- Positive serologic HIV test at screening
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology). Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These participants must be willing to undergo monthly DNA testing and appropriate prophylactic antiviral therapy as indicated.
- Acute or chronic hepatitis C virus (HCV) infection. Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.
- Known or suspected chronic active Epstein Barr Virus infection (CAEBV).
- Patients with history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH)
- Received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment.
- Left ventricular ejection fraction (LVEF) <50% by multiple-gated acquisition (MUGA) scan or echocardiogram.
- Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:
- significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmia, or unstable angina)
- significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
- clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis.
- current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
- Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past year and have no residual neurologic deficits as judged by the investigator are allowed.
- Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible.
- Recent major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
- Participants who are in dependence to the Sponsor or an investigator.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Spain16 sites, 9 recruiting
- Recruiting
Hospital Vall Hebron
Barcelona, Barcelona, 08035
Pau Abrisqueta Costa, Dr, +34 932746100, pabrisqueta@vhio.net
- Recruiting
Hospital Clínic y Porvincial de Barcelona
Barcelona, Barcelona, 08036
Pablo Javier Mozas Fernández, Dr, +34 93 227 54 00 ext. 4930, MOZAS@clinic.cat
- Recruiting
Hospital de Donostia
Donostia / San Sebastian, San Sebastian, 20014
Izaskun Ceberio Echechipia, Dra, +34 943 328 123, izaskun.ceberioechechipia@osakidetza.eus
- Recruiting
ICO Hospitalet Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Ana Oliveira Ramos, Dra, +34 932607750, acoliveira@iconcologia.net
- Active, not recruiting
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35010
- Recruiting
Hospital Universitario La Princesa
Madrid, Madrid, 28006
Luis Miguel Júarez Salcedo, Dr, +34 626708579, dr.luisjuarez@gmail.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Javier De la Serna Torroba, Dr, +34 91 779 28 79, drjdelaserna@gmail.com
- Active, not recruiting
Hospital Universitario Costa del Sol
Marbella, Málaga, 29603
- Active, not recruiting
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Angel Ramirez Payer, Dr, +34 985 65 24 89, apayer.angel@gmail.com
- Active, not recruiting
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
- Recruiting
H Marqués de Valdecilla
Santander, Cantabria, 39011
Lucrecia Yañez San Segundo, Dr, lucrecia.yanez@scsalud.es
- Recruiting
Centro Hospitalario Universitario de Santiago
Santiago de Compostela, Santiago de Compostela, 15706
Adrian Mosquera Orgeira, Dr, +34 981950000 ext. 250191, Adrian.Mosquera.Orgeira@sergas.es
- Active, not recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
- Active, not recruiting
Hospital Universitario Clínico de Valencia
Valencia, Valencia, 46010
- Active, not recruiting
Hospital Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
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
Read the detailed description
Patients with Richter´s Syndrome received 6 cycle of Mosunetuzumab+CHOP. At the EoI, in patients achieving stable disease (SD) or in patients with partial response (PR) or complete response (CR) who are not candidates to consolidation with cellular therapy, mosunetuzumab as monotherapy will be administered over eleven 21-day cycles (approximately 10 months) or until disease progression or unacceptable toxicity, whichever occurs first.
- Conditions
- Richter Syndrome
- Being tested
- Mosunetuzumab (IV)
- Keywords
- Richter Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosunetuzumab (IV)Drug
6 cycle of Mosunetuzumab+CHOP and then 11 cycles more of mosunetuzumab on mnotherapy
| Study group | Role | What they receive |
|---|---|---|
| Mosunetuzumab | Experimental | 6 cycle of mosunetuzumab+CHOP and then 11 cycles more of Mosunetuzumab on monotherapy. Receives: Drug: Mosunetuzumab (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 6 cycles (up to 6 months)
Secondary outcomes (6)
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
Measured: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
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.
Measured: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
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
Measured: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
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
Measured: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
To determine the incidence and severity of adverse events.
Incidence of adverse events (AEs): number and percentage of patients with 1 or more AE.
Severity of AEs. Treatment duration. Total dose received. Number of cycles and dose modifications. Treatment interruptions and discontinuations
Measured: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to11 months)
To evaluate the study treatment exposure.
Incidence of adverse events (AEs): number and percentage of patients with 1 or more AE.
Severity of AEs. Treatment duration. Total dose received. Number of cycles and dose modifications. Treatment interruptions and discontinuations
Measured: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more- up to 11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start15 May 2024
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Richter SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 6 cycle of Mosunetuzumab+CHOP and den 11 cycle more of mosunetuzumab on monotherapy to first line of patients with Richter Syndrome
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GELLC (Grupo Español de Leucemia Linfocítica Crónica)
- Sponsor type
- University, hospital or other
- Collaborators
- Evidenze CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926205
- Sponsor's protocol ID
- GELLC-9-RICHTER/M043880
- Other IDs
- 2023-505621-13-00, 2023
- Acronym
- GELLC9RICHTER
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD are property of sponsor of study and not share with any researcher
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL
- ClinicalTrials.gov ID
- NCT06926205
- Acronym / sponsor ID
- GELLC9RICHTER / GELLC-9-RICHTER/M043880
- Conditions
- Richter Syndrome
- Keywords
- Richter Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- GELLC (Grupo Español de Leucemia Linfocítica Crónica)University, hospital or other
- Collaborators
- Evidenze CRO
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients with Richter´s Syndrome received 6 cycle of Mosunetuzumab+CHOP. At the EoI, in patients achieving stable disease (SD) or in patients with partial response (PR) or complete response (CR) who are not candidates to consolidation with cellular therapy, mosunetuzumab as monotherapy will be administered over eleven 21-day cycles (approximately 10 months) or until disease progression or unacceptable toxicity, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 6 cycle of Mosunetuzumab+CHOP and den 11 cycle more of mosunetuzumab on monotherapy to first line of patients with Richter Syndrome
| Arm | Type | Receives |
|---|---|---|
| Mosunetuzumab | Experimental | Drug: Mosunetuzumab (IV)6 cycle of mosunetuzumab+CHOP and then 11 cycles more of Mosunetuzumab on monotherapy. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
- Adult patients with previously untreated, histologically proven Richter's syndrome, diffuse large B cell variants, following WHO 2008 criteria (Swerdlow SH, 2008).
Key exclusion criteria (50 listed)
- Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab.
- Participants who have received any of the following treatments prior to study entry:
- Participants who have received any of the following treatments, whether investigational or approved, given to treat RS, within the respective time periods prior to initiation of study treatment:
- Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
- Transformation of CLL to prolymphocytic leukemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mosunetuzumab (IV)6 cycle of Mosunetuzumab+CHOP and then 11 cycles more of mosunetuzumab on mnotherapy | Drug | Mosunetuzumab |
Primary outcome
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)
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.
6 secondary outcomes
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
Time frame: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
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
Time frame: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
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
Time frame: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
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
Time frame: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to 11 months)
To determine the incidence and severity of adverse events.
Time frame: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more-up to11 months)
To evaluate the study treatment exposure.
Time frame: During induction ( 6 Cycles- up to 6 months) and manteinace ( 11 cycles more- up to 11 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No. The IPD are property of sponsor of study and not share with any researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mosunetuzumab (IV) in people with Richter Syndrome, run by GELLC (Grupo Español de Leucemia Linfocítica Crónica) at 16 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Méndez, Sponsor representative (+34 942 203450, administracion@gellc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.