Actively Recruiting
Orelabrutinib with Rituximab and Optional Stem Cell Transplantation for Treatment-Naive Non-High-Risk Mantle Cell Lymphoma
Led by Ruijin Hospital · Updated on 2025-09-30
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
F
Fujian Medical University Union Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of orelabrutinib combined with rituximab, with an option for autologous hematopoietic stem cell transplantation (ASCT), in patients with non-high-risk mantle cell lymphoma (MCL). This open-label, multicenter trial focuses on treatment-naive patients and aims primarily to measure the complete response rate after the induction phase. Secondary goals include assessing progression-free survival, overall survival, objective response rate, and safety, alongside exploring how tumor biomarkers relate to treatment response. During the induction phase, patients receive rituximab intravenously at specified days in the first cycle and then on day 1 of each 28-day cycle for six cycles, alongside daily oral orelabrutinib. Patients who respond to induction and qualify may proceed to ASCT with BEAM pretreatment consisting of carmustine, etoposide, cytarabine, and melphalan administered over several days. Following induction or transplantation, patients enter a maintenance phase receiving daily oral orelabrutinib until disease progression or unacceptable side effects occur. Participants will undergo regular assessments throughout the study, including evaluations for complete response approximately 6 to 8 weeks after induction. Researchers will monitor overall response, survival outcomes, and safety over up to about three years. The study includes laboratory tests and clinical monitoring to track disease status and treatment effects. Total participation may extend from treatment through long-term follow-up phases, ensuring close observation of health and response to therapy.
CONDITIONS
Brief Title
Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with mantle cell lymphoma confirmed by flow cytometry or histopathology and have not received prior treatment
- Aged 14 years or older, any gender
- Ann Arbor stage II-IV; stage II patients must require systemic therapy as judged by the investigator
- At least one measurable lesion
- Blood tests showing white blood cell count ≥3.0x10^9/L, neutrophil count ≥1.5x10^9/L, hemoglobin ≥90 g/L, platelet count ≥75x10^9/L
- Liver function within 2.5 times the upper normal limit for transaminases and 1.5 times for bilirubin
- Serum creatinine between 44 and 133 mmol/L
- Estimated life expectancy over 12 weeks from screening
- Willing and able to comply with all study assessments and procedures
You will not qualify if you...
- Previous treatment with BTK inhibitors
- Presence of high-risk factors including MIPI score 6-11, Ki67 over 30%, TP53 abnormality, or blastic/pleomorphic variants
- Severe complications or serious infections
- Uncontrolled heart diseases, coagulation disorders, connective tissue diseases, or serious infectious diseases
- Active infections needing systemic treatment such as bacterial, fungal, or viral infections
- HIV infection
- Mental disorders or inability to comply with the study protocol
- Other conditions judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 cycles of 28 days each
Participants receive rituximab intravenously on specific days in each 28-day cycle and take orelabrutinib orally daily for 6 cycles.
Weekly visits during Cycle 1 and 1 visit per cycle afterwards for 6 cycles
Duration - Approximately 1 month including pretreatment and transplantation
Participants who respond to induction therapy and are eligible will undergo stem cell transplantation with BEAM chemotherapy pretreatment.
Multiple visits around transplantation days (-7 to -2) and immediate post-transplant care
Duration - Variable duration until progression or toxicity
Participants take orelabrutinib orally daily until disease progression or intolerable toxicity.
Regular visits as determined by the study protocol
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China, 200025
Actively Recruiting
Research Team
L
Li Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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