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New treatment option for Mantle Cell Lymphoma (MCL)
Official title Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
ClinicalTrials.gov ID: NCT06496308
What this study is testing
What is Orelabrutinib?
Orelabrutinib is an investigational medicine, being studied as a potential treatment for mantle cell lymphoma (mcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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 people, 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.
You likely can't join if
- Patients who have previously received treatment with BTK inhibitors.
- Patients with severe complications or serious infections.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
- Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
- HIV-infected individuals.
- Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.
See the full eligibility criteria
- 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 people, 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...
- 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.
- Patients who have previously received treatment with BTK inhibitors.
- Patients with severe complications or serious infections.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
- Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
- HIV-infected individuals.
- Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.
- Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.