A Study of ICP-022 in Patients With R/R DLBCL

Phase 2

Completed

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: ICP-022

• Registration Number: NCT04438005
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary

It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-07
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Primary Completion: 2021-11-05
• Study Completion: 2021-12-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICP-022	ICP-022	-

Primary Outcome Measures

Name	Time	Method
Overall response rate（ORR）	Up to 3 years	The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events and serious adverse events	Up to 3 years	The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria
Progression free survival（PFS）	Up to 3 years	The efficacy measured by progression free survival（PFS）
Duration of response（DOR）	Up to 3 years

Trial Locations

Locations (7)

Affiliated Tumor Hospital of Harbin Medical University; 🇨🇳 Haerbin, Heilongjiang, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences); 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Hangzhou, Zhejiang, China

The Fourth Hospital of Hebei Medical University; 🇨🇳 Hebei, Shijiazhuang, China