This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy.
This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy. Patients experiencing failure after CAR-T cell treatment will be screened for inclusion and exclusion criteria for treatment and, if eligible, will enter the study. Safety events will be analyzed and compared with the previously described safety profile of glofitamab alone and other bispecific-containing regimens to exclude the risk of potential toxicity for all study participants. The study will include a period of screening phase, a period of treatment phase and a follow up phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Glofitamab treatment in post CAR-T R/R MCL patients
AOU SS. Antonio e Biagio e Cesare Arrigo - SCDU Ematologia
Alessandria, Italy
NOT_YET_RECRUITINGComplete Response Rate (CRR)
Complete Response Rate (CRR) at the end of treatment (C12) (assessed by the independent review committee according to Lugano 2014 criteria) and at any time during study treatment.
Time frame: 27 months
Overall Response Rate (ORR)
Overall Response Rate (ORR) defined as the proportion of patients achieving either a Complete Response (CR) or Partial Response (PR) (assessed by the independent review committee according to Lugano 2014 criteria), and evaluated at C6 and C12.
Time frame: 27 months
Progression Free Survival (PFS)
Progression Free Survival (PFS) defined as the time from the study inclusion to disease progression or death from any cause.
Time frame: 51 months
Overall Survival (OS)
Overall Survival (OS) defined as the time between the study inclusion and death from any cause.
Time frame: 51 months
Duration of Response (DOR)
Duration of Response (DOR) defined as the time from the first documentation of tumor response (Complete or Partial Response) to disease progression or death.
Time frame: 51 months
Time to Next Treatment (TTNT)
Time to Next Treatment (TTNT) defined as the time represents the interval from the study inclusion to initiation of the next line of therapy.
Time frame: 51 months
Event Free Survival (EFS)
Event Free Survival (EFS) defined as the time from the study inclusion to disease progression, death, or Next Anti-Lymphoma Treatment (NALT) start.
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Policlinico S.Orsola-Malpighi - Istituto di Ematologia Seragnoli
Bologna, Italy
ASST Spedali Civili - Ematologia
Brescia, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy
NOT_YET_RECRUITINGOspedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia - Ematologia e terapie cellulari
Genova, Italy
NOT_YET_RECRUITINGASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
NOT_YET_RECRUITINGA.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo, Italy
NOT_YET_RECRUITINGP.O. Spirito Santo di Pescara - UOC Ematologia Dipartimento Oncologico Ematologico - ASL Pescara
Pescara, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria Pisana - U.O. Ematologia
Pisa, Italy
NOT_YET_RECRUITINGGrande Ospedale Metropolitano Bianchi Melacrino Morelli - C.T.M.O.
Reggio Calabria, Italy
RECRUITING...and 4 more locations
Time frame: 51 months
AEs
Frequency and severity of adverse events (AEs) classified as per CTCAE (Common Terminology Criteria for Adverse Events) latest version and SAE.
Time frame: 51 months