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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ICP-022
Sponsored by
Beijing InnoCare Pharma Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Relapsed/Refractory

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Affiliated Tumor Hospital of Harbin Medical UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • The Fourth Hospital of Hebei Medical UniversityRecruiting
  • Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)Recruiting
  • The First Affiliated Hospital of Zhejiang University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICP-022

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate（ORR）
The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL

Secondary Outcome Measures

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
Progression free survival（PFS）
The efficacy measured by progression free survival（PFS）
Duration of response（DOR）

Full Information

First Posted
June 16, 2020
Last Updated
August 23, 2022
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04438005
Brief Title
A Study of ICP-022 in Patients With R/R DLBCL
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
Relapsed/Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICP-022
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ICP-022
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate（ORR）
Description
The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Occurrence of adverse events and serious adverse events
Description
The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria
Time Frame
Up to 3 years
Title
Progression free survival（PFS）
Description
The efficacy measured by progression free survival（PFS）
Time Frame
Up to 3 years
Title
Duration of response（DOR）
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion criteria： 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. Key Exclusion criteria: 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Jin, PhD
Phone
13750853563
Email
Jiej0503@163.com
Facility Information:
Facility Name
Affiliated Tumor Hospital of Harbin Medical University
City
Haerbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Xu
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Yang
Facility Name
The Fourth Hospital of Hebei Medical University
City
Hebei
State/Province
Shijiazhuang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Liu
Facility Name
Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liu
Facility Name
The First Affiliated Hospital of Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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