Tests orelabrutinib with standard chemotherapy in newly diagnosed mantle cell lymphoma
Tests orelabrutinib added to standard treatment in adults newly diagnosed with mantle cell lymphoma.
Plain-language title generated from the registry record
Registry title: A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Key facts
- Where
- Cracow, Katowice, Lodz, Lublin, Skorzewo, Torun, Warsaw, and Wroclaw, PolandSee the 8 sites
- Phase
- Phase 3
Where in Poland
- Pratia S.A.Cracow, PolandTaking people
- Pratia Hematologia Sp. Z o. oKatowice, PolandTaking people
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziLodz, PolandTaking people
- Uniwersytecki Szpital Kliniczny Nr 1 w LublinieLublin, PolandTaking people
- Aidport sp z o.o.Skorzewo, PolandTaking people
- Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, PolandTaking people
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandTaking people
- Pratia S.A.Wroclaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- InnoCare Pharma Inc.
- Trial code
- NCT06363994EU 2025-524241-27-00
- Record updated
- 27 December 2024
- Original description
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)Read full original descriptionShow less
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Inclusion: 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; 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 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.
Exclusion: Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy; Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant; 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; Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening; Known central nervous system lymphoma.