NCT06363994RecruitingPhase 3
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
InnoCare Pharma Inc.38 sites in 1 country476 target enrollmentStarted: May 29, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 476
- Locations
- 38
- Primary Endpoint
- Dose-limiting toxicity (DLT)
Study Overview
Brief Summary
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects ≥ 65 of age, or ≥ 60 and < 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
- •Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
- •Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
- •At least one measurable site of disease (the longest axis of the lymph node lesion is > 1.5 cm, or the longest diameter of the extranodal lesion is > 1.0 cm).
- •ECOG PS score of 0 to 2.
Exclusion Criteria
- •Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- •Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
- •Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
- •Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
- •Known central nervous system lymphoma.
Arms & Interventions
Arm A
Active Comparator
Intervention: Orelabrutinib (Drug)
Arm A
Active Comparator
Intervention: Bendamustine Injection (Drug)
Arm A
Active Comparator
Intervention: Rituximab (Drug)
Arm B
Active Comparator
Intervention: Bendamustine Injection (Drug)
Arm B
Active Comparator
Intervention: Rituximab (Drug)
Arm B
Active Comparator
Intervention: Orelabrutinib Placebo (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity (DLT)
Time Frame: 28 days
Progression-free Survival (PFS) for Arm A vs. Arm B
Time Frame: Approximately 7 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (38)
Loading locations...
Similar Trials
Recruiting
Phase 3
Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone LymphomaRelapsed/Refractory Marginal Zone LymphomaNCT06082102Beijing InnoCare Pharma Tech Co., Ltd.324
Recruiting
Not Applicable
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local TherapyMarginal Zone LymphomaNCT06478472The First Affiliated Hospital of Xiamen University36
Completed
Phase 3
Bendamustine Plus Rituximab Versus Fludarabine Plus RituximabNon-Hodgkin's LymphomaMantle Cell LymphomaNCT01456351University of Giessen230
Unknown
Phase 3
Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular LymphomaFollicular LymphomaNCT02423837National Research Center for Hematology, Russia200
Active, not recruiting
Phase 3
A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone LymphomaMarginal Zone LymphomaNCT04212013Memorial Sloan Kettering Cancer Center23