Comparing Orelabrutinib with standard treatment for mantle cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of Orelabrutinib combined with bendamustine and rituximab compared to the standard treatment of bendamustine and rituximab alone in patients with previously untreated mantle cell lymphoma (MCL). The study aims to enroll patients aged 60 and older who are not candidates for stem cell transplantation. Participants will be assessed for measurable disease and must have a confirmed diagnosis of MCL. The trial is designed to provide insights into the potential benefits of Orelabrutinib in improving treatment outcomes for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects ≥ 65 of age, or ≥ 60 and \< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
3. 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.
4. 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).
5. ECOG PS score of 0 to 2.

Exclusion Criteria:

1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
4. Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
5. Known central nervous system lymphoma.

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting
• Peking University Third Hospital
  Beijing, China Recruiting
• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, China Recruiting
• Hunan Cancer Hospital
  Changsha, China Recruiting
• Sichuan Provincial People's Hospital
  Chengdu, China Recruiting
• Chongqinq Cancer Hospital
  Chongqing, China Recruiting

Study contacts

• Study coordinator: Alexia Lu
• Email: CO_HGRAC@innocarepharma.com
• Phone: 010-66609745

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Orelabrutinib plus rituximab with optional lenalidomide for untreated marginal zone lymphoma using a response-adapted plan

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  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07448324

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  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07410520

• Orelabrutinib with lisaftoclax and rituximab for untreated high-risk mantle cell lymphoma

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• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

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• Orelabrutinib plus zebetuzumab and lenalidomide vs bendamustine‑rituximab for newly diagnosed marginal zone lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.