The First Affiliated Hospital of Nanchang University
Conditions
Brief summary
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
Detailed description
The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy
Interventions
DRUGOrelabrutinib+R-CHOP
Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.
Sponsors
The First Affiliated Hospital of Nanchang University
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma * Age 18-70 years * ECOG performance status 0-2 * Ann Arbor stage II-IV * 8.Subjects who in line with the testing standard of the clinical trial laboratory * Life expectancy ≥ 3months
Exclusion criteria
* • systemic lymphoma involved CNS. * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases. * uncontrolled infections (including HBV, HCV, HIV/AIDS) * Subjects who prepared for transplantation * Pregnancy or active lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate | up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 24 weeks | ORR is defined as the proportion of patients with a best response of CR or PR |
| 2 years progression-free survival | From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years] | 2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing |
| 2 years overall survival | From date of receiving the first dose until the date of death from any cause,assessed up to 2 years | 2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive |
| The occurrence of adverse events and serious adverse events | up to 30 months | Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0. |
Countries
China
Contacts
Primary Contactzengjun Li
Backup ContactDan Liu
Outcome results
None listed