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

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Trial Details

NCT ID
NCT06363994
Phase
PHASE3
Sponsor
InnoCare Pharma Inc.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Orelabrutinib
  • Bendamustine Injection
  • Rituximab
  • Orelabrutinib Placebo
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Bengbu, China|32.94083,117.36083
  • Changchun, China|43.88,125.32278
  • Changsha, China|28.19874,112.97087

Key Eligibility Criteria

  • 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 reas…
  • Modified Ann Arbor stage II-IV. Patients 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 mus…
  • 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 i…

For full eligibility, visit ClinicalTrials.gov.

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