A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.

• Age \> 18 years of age, both genders are eligible.

• Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.

• At least one measurable lesion.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

• Any one of the following high-risk factors is present: MIPI score of 4-11, Ki67 \> 50%, TP53 abnormality, blastic or pleomorphic variation.

• Patients who are not suitable candidates for autologous hematopoietic stem cell transplantation.

• Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, hemoglobin ≥90g/L, platelet count ≥75×10\^9/L. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol/L.

• The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.

• Willing and able to participate in all required assessments and procedures of the study protocol.

Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Weili Zhao
zhao.weili@yahoo.com
+862164370045
Backup
Li Wang
wl11194@rjh.com.cn
+862164370045
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2027-07-10
Participants
Target number of participants: 78
Treatments
Experimental: Orelabrutinib + Bendamustine + Rituximab (OBR)
In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in OBR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, and orelabrutinib 150mg/day PO once daily, every 28 day per cycle for 6 cycles.
Placebo_comparator: Bendamustine + Rituximab (BR)
In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in BR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, every 28 day per cycle for 6 cycles.
Other: Orelabrutinib + Venetoclax (OV)
In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients with TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily and venetoclax for up to 2 years, the dosing of Venetoclax is escalated gradually to reach a target dose of 400 mg.
Other: Orelabrutinib (O)
In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients without TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily for up to 2 years.
Sponsors
Collaborators: Jiangxi Provincial Cancer Hospital, Fujian Medical University Union Hospital, The First Affiliated Hospital of Anhui Medical University, Third Xiangya Hospital of Central South University, Yantai Yuhuangding Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, Fujian Cancer Hospital, Anhui Provincial Cancer Hospital
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials