Treatment-naїve mantle cell lymphoma (MCL)
Conditions
Brief summary
Randomization Stage: Progression-free survival (PFS) assessed by Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL)
Detailed description
Randomization Stage: Overall Survival (OS), Randomization Stage: Efficacy Endpoints o PFS assessed by Investigator according to iwNHL o ORR, CRR. DOR and TTR assessed by IRC and Investigator according to iwNHL Time to next treatment (TTNT), Randomization Stage: Safety Endpoints AEs assessed by CTCAE v5.0 criteria, VS, PE, ECG, ECOG performance status and laboratory findings, Randomization Stage: o PK Endpoint o Plasma concentrations of orelabrutinib, Randomization Stage: Assessment of Patient-Reported Outcomes o Quality of life assessment: Time to worsening, health score and changes from baseline in FACT-Lym and EQ-5D-5L
Interventions
Sponsors
Innocare Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Randomization Stage: Progression-free survival (PFS) assessed by Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL) | — |
Secondary
| Measure | Time frame |
|---|---|
| Randomization Stage: Overall Survival (OS), Randomization Stage: Efficacy Endpoints o PFS assessed by Investigator according to iwNHL o ORR, CRR. DOR and TTR assessed by IRC and Investigator according to iwNHL Time to next treatment (TTNT), Randomization Stage: Safety Endpoints AEs assessed by CTCAE v5.0 criteria, VS, PE, ECG, ECOG performance status and laboratory findings, Randomization Stage: o PK Endpoint o Plasma concentrations of orelabrutinib, Randomization Stage: Assessment of Patient-Reported Outcomes o Quality of life assessment: Time to worsening, health score and changes from baseline in FACT-Lym and EQ-5D-5L | — |
Outcome results
None listed