CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 150 target
Drug / intervention
Orelabrutinib + R-CHOP +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05234684
NCT05234684Phase 3Unknown
CompareCT.gov

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-naïve Patients With MCD Subtype DLBCL

Beijing InnoCare Pharma Tech Co., Ltd.·interventional·Posted Feb 10, 2022·Updated Feb 7, 2024

In Brief

A Phase 3 clinical trial evaluating Orelabrutinib + R-CHOP and Placebo + R-CHOP for Diffuse Large B Cell Lymphoma (DLBCL). Targeting 150 participants across 44 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP regimen versus placebo with R-CHOP in the treatment of treatment-naïve patients with MCD subtype DLBCL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B Cell Lymphoma (DLBCL)
CountriesChina
Collaborators--

Timeline

Phase 3UnknownOverdue
20222023202420252026
First PostedFeb 10, 2022
Enrollment StartNov 2, 2022
Primary CompletionJul 30, 2024
Study CompletionDec 30, 2025
TodayJul 1, 2026
Enrollment to primary: 1.7 yearsPosted 4.4 years ago

Interventions

Orelabrutinib + R-CHOPdrug

The orelabrutinib is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.

Placebo + R-CHOPdrug

The placebo is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.