NCT06363994 A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
| NCT ID | NCT06363994 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | InnoCare Pharma Inc. |
| Condition | Mantle Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 476 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2031-06-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 476 participants in total. It began in 2024-05-29 with a primary completion date of 2031-06-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06363994 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Mantle Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06363994 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 476 participants.
Is NCT06363994 currently recruiting?
Yes, NCT06363994 is actively recruiting participants. Contact the research team at CO_HGRAC@innocarepharma.com for enrollment information.
Where is the NCT06363994 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Bengbu, China, Changchun, China and 11 additional locations.
Who is sponsoring the NCT06363994 clinical trial?
NCT06363994 is sponsored by InnoCare Pharma Inc.. The trial plans to enroll 476 participants.