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

NCT04438005 | Completed Phase 2

• 1 other identifier: ICP-CL-00108
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 7

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Relapsed/Refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Occurrence of adverse events and serious adverse events

  Up to 3 years

• Progression free survival（PFS）

  Up to 3 years

• Duration of response（DOR）

  Up to 3 years

Study Arms (1)

ICP-022

EXPERIMENTAL

Drug: ICP-022

Interventions

ICP-022 DRUG

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.

ICP-022

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 18 and 75 years old,
• 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,
• ECOG performance status of 0-2,
• Voluntary written informed consent prior to trail screening.

You may not qualify if:

• History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry
• History of Richter's syndrome
• Current or history of lymphoma involved central nervous system
• 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.
• The investigator considers other conditions unsuitable for this study.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (7)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Affiliated Tumor Hospital of Harbin Medical University

Haerbin, Heilongjiang, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

The Fourth Hospital of Hebei Medical University

Hebei, Shijiazhuang, China

Location

Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: May 7, 2020
• Primary Completion: November 5, 2021
• Study Completion: December 13, 2021
• Last Updated: May 13, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)