Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
ConditionMCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be ≥ 18 years of age.
Subject must have a confirmed Mantle Cell Lymphoma (MCL) diagnosis according to WHO (2008) criteria.
Previously untreated MCL
Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
Disqualifiers
Subject has known central nervous system involvement by MCL.
Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
Receiving any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inhibitor or inducer within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug or requiring long-term use of strong CYP3A4 inhibitors or inducers.
Prior ASCT within the last 3 months; or prior autologous chimeric antigen receptor-T cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
Trial design
Design model
Single group
Treatments tested in this trial
BGB-11417
DrugSonrotoclax, orally, 320 mg once daily following a weekly ramp-up schedule
BGB-3111
DrugZanubrutinib, orally, 320 mg total daily dose
CD20
DrugCD20mab is recommened as Rituximab as per the protocol, other CD20mab is also allowed.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment armExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
CR (complete response) rate at cycle 12 by investigator (INV).
Complete response rate (CRR) of the study population from the initiation of the first cycle treatment. CRR is defined as the proportion of patients that achieved the best response of CR, determined by INV.
Time frame
From enrollment to the end of treatment at the end of cycle 12 (each cycle is 28 days)Secondary outcomes
1
ORR (Overall response rate)
ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV -PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV.
Time frame
From enrollment to the end of treatment at the end of cycle 36 (each cycle is 28 days)2
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause.
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov