What is Orelabrutinib studying for mantle cell lymphoma?

Orelabrutinib is being studied to see if adding it to the usual bendamustine and rituximab treatment improves outcomes for patients with mantle cell lymphoma who have not had prior treatment. The study sponsored by InnoCare Pharma Inc. compares this combination to the standard therapy. Participants will help researchers understand how well the new combination works and its safety.

Who may be eligible for this mantle cell lymphoma clinical trial?

Adults aged 60 years and older with a confirmed diagnosis of mantle cell lymphoma who have not received prior treatment may be eligible. Both men and women can join, but participants should not have active other cancers or serious gastrointestinal issues affecting medication absorption. Please review eligibility criteria for more details.

Is there any cost to participate in this mantle cell lymphoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or lodging expenses.

Actively Recruiting

Phase 3

Age: 60Years +

All Genders

ID06363994

Phase 3 Study Comparing Orelabrutinib Plus Bendamustine and Rituximab Versus Bendamustine and Rituximab Alone in Patients with Untreated Mantle Cell Lymphoma Aged 60 and Older

Led by InnoCare Pharma Inc. · Updated on 2024-12-27

476

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of adding Orelabrutinib to a standard treatment of bendamustine plus rituximab in patients who have not previously been treated for mantle cell lymphoma MCL. This phase 3, randomized, double-blind study aims to compare the combination of Orelabrutinib with bendamustine and rituximab versus bendamustine and rituximab alone. The study is sponsored by InnoCare Pharma Inc. and focuses on patients with treatment-naive MCL, typically older adults. Participants will be randomly assigned to one of two groups one receiving Orelabrutinib orally along with bendamustine and rituximab injections, and the other receiving a placebo oral treatment with bendamustine and rituximab injections. Treatment will continue until the disease progresses or other reasons require stopping. The study uses a quadruple masking design, ensuring that participants and researchers do not know who is receiving Orelabrutinib or placebo. Throughout the study, participants will be monitored for dose-limiting toxicity within the first 28 days and followed for progression-free survival over approximately seven years. Researchers will conduct assessments to track disease status, side effects, and overall health. The trial involves regular visits, laboratory tests, and imaging to evaluate treatment effects and safety. Participants involvement may last several years, including long-term follow-up to understand treatment outcomes and risks.

CONDITIONS

Brief Title

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

Who Can Participate

Age: 60Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 65 or older, or age 60 to under 65 if ineligible for or refusing stem cell transplant
No prior systemic therapy for mantle cell lymphoma
Modified Ann Arbor stage II-IV; stage II patients require systemic treatment
Confirmed mantle cell lymphoma with Cyclin D1 expression and/or t (11; 14) chromosomal translocation
At least one measurable disease site (lymph node > 1.5 cm or extranodal lesion > 1.0 cm)
ECOG performance status of 0 to 2

You will not qualify if you...

History of other malignant tumors with no recurrence or metastasis within 2 years before screening
Gastrointestinal dysfunction affecting drug intake or total gastrectomy
Therapy aimed at tumor debulking before stem cell transplant
Use or planned use of strong cytochrome P450 3A inhibitors or inducers within 14 days or 5 half-lives before first study dose
Known central nervous system lymphoma

Research Team

Alexia Lu

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