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A phase 3 study of orelabrutinib in combination with rituximab plus bendamustine (BR) compared with BR in subjects with treatment-naїve mantle cell lymphoma
EU CTIS ID: 2025-524241-27-00
What this study is testing
Randomization Stage: To compare the effect of orelabrutinib plus BR vs BR on PFS in treatment-naїve subjects with MCL
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects ≥ 65 of age, or ≥ 60 and < 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation.
- Have not received prior systemic therapies for MCL.
- Modified Ann Arbor stage II-IV. Subjects 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
You likely can't join if
- Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- Uncontrolled or significant cardiovascular diseases
- History of hemophilia A, hemophilia B, von Willebrand disease or requiring anticoagulation with warfarin or equivalent vitamin K antagonists or have a spontaneous bleeding tendency assessed by the Investigator.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study treatment.
- Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects who have undergone total gastrectomy.
- Have undergone major surgery within 30 days prior to the first dose of study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- China
- Ukraine
- Australia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; China; Ukraine; Australia. 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 EU CTIS; the study team decides eligibility.