A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

Study Overview
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Brief Summary
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To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.

Official Title
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A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

Conditions
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Treatment-naїve Mantle Cell Lymphoma

Intervention / Treatment
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* Drug: Orelabrutinib and R-CHOP
* Drug: R-CHOP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report. No previous systemic treatment for MCL. ECOG physical strength score is 0-2. Expected survival time >6 months. Voluntary written informed consent prior to screening. Exclusion Criteria: Uncontrolled or significant cardiovascular diseases History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance; Pregnant or breastfeeding women and those who do not agree to take contraceptive measures. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the experimental group<br>Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) | Drug: Orelabrutinib and R-CHOP<br>* Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)<br>|
| Experimental: The control group<br>R-CHOP | Drug: R-CHOP<br>* Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL). | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | Up to 6 years | 
| CRR | Complete Response Rate | Up to 6 years | 
| OS | Overall Survival | Up to 6 years |