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

Diffuse Large B Cell Lymphoma Clinical Trial

— DLBCL  

Official title:

A Multicenter, Open-Label Study to Investigate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04438005
• Other study ID #: ICP-CL-00108
• Status: Completed
• Phase: Phase 2
• Start date: May 7, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: April 2024
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 13, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion criteria:

1. Men and women between 18 and 75 years old,

2. Histologically confirmed diffuse large B-cell lymphoma(DLBCL)with MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI,

3. ECOG performance status of 0-2,

4. Voluntary written informed consent prior to trail screening.

Key Exclusion criteria:

1. History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry

2. History of Richter's syndrome

3. Current or history of lymphoma involved central nervous system

4. Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug.

5. The investigator considers other conditions unsuitable for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• ICP-022
ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Affiliated Tumor Hospital of Harbin Medical University	Haerbin	Heilongjiang
China	The First Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang
China	The Fourth Hospital of Hebei Medical University	Hebei	Shijiazhuang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate(ORR)	The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL	Up to 3 years
Secondary	Occurrence of adverse events and serious adverse events	The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria	Up to 3 years
Secondary	Progression free survival(PFS)	The efficacy measured by progression free survival(PFS)	Up to 3 years
Secondary	Duration of response(DOR)		Up to 3 years