Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
476
Eligible patients will receive Orelabrutinib orally as per the protocol,until disease progression or other reasons for treatment discontinuation,whichever comes first.
Eligible patients will receive Bendamustine by injection as per the protocol
Eligible patients will receive Rituximab by injection as per the protocol
Dose-limiting toxicity (DLT)
Time frame: 28 days
Progression-free Survival (PFS) for Arm A vs. Arm B
Time frame: Approximately 7 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
Beijing Cancer Hospital
Beijing, China
RECRUITINGPeking University Third Hospital
Beijing, China
RECRUITINGThe First Affiliated Hospital of Bengbu Medical University
Bengbu, China
RECRUITINGFirst Hospital of Jilin University
Changchun, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, China
RECRUITINGThe First People's Hospital of Changzhou
Changzhou, China
NOT_YET_RECRUITINGSichuan Provincial People's Hospital
Chengdu, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, China
NOT_YET_RECRUITINGChongqinq Cancer Hospital
Chongqing, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, China
NOT_YET_RECRUITING...and 29 more locations