Treatment-naїve Mantle Cell Lymphoma
Conditions
Brief summary
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.
Interventions
DRUGOrelabrutinib and R-CHOP
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
DRUGR-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 65 \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator 2. 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. 3. No previous systemic treatment for MCL. 4. ECOG physical strength score is 0-2. 5. Expected survival time \>6 months. 6. Voluntary written informed consent prior to screening.
Exclusion criteria
1. Uncontrolled or significant cardiovascular diseases 2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment. 3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance; 4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures. 5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to 6 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Up to 6 years | Objective Response Rate |
| CRR | Up to 6 years | Complete Response Rate |
| OS | Up to 6 years | Overall Survival |
Countries
China
Outcome results
None listed