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A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia

Primary Purpose

Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory

Status
Active
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 Waldenstrom's Macroglobulinemia Recurrent

Eligibility Criteria

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

Key Inclusion criteria:

  1. Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003)
  2. At least one treatment indication is met (7th WM International Working Group standards, IWWM-7) (Dimopoulos et al., 2014)
  3. With the lowest serum IgM value >2 times ULN as the efficacy evaluation index
  4. ECOG physical strength score 0-2
  5. Voluntary written informed consent prior to trial screening.

Key Exclusion Criteria:

  1. Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
  2. Amyloidosis and central nervous system (CNS) involvement caused by WM
  3. Demonstrate disease transformation
  4. Patients who had received autologous stem cell transplantation within the previous 6 months
  5. A history of organ transplantation or allogeneic bone marrow transplantation

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

Sites / Locations

  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  • West China hospital of sichuan university
  • Union Hospital affiliated to Fujian Medical University
  • The First Affiliated Hospital of Xiamen University
  • First Affiliated Hospital of Zhengzhou University
  • Henan Cancer Hospital
  • Henan Provincial Peoples's Hospital
  • Tongji Hospital affiliated to Huazhong University of Science and Technology
  • Jiangsu Province Hospital
  • The First Affiliated Hospital of Soochow University
  • Shengjing Hospital of China Medical University
  • Ruijin Hospital affiliated to Shanghai Jiao Tong University
  • Hospital of Hematology, Chinese Academy of Medical Sciences
  • Union Hospital affiliated to Huazhong University of Science and Technology
  • The First Affiliated Hospital of Zhejiang University Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICP-022

Arm Description

Subjects will take ICP-022 150mg once daily (QD).

Outcomes

Primary Outcome Measures

Major response rate（MRR）

Secondary Outcome Measures

The 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 4.03 grading criteria
Duration of Major Mitigation (DOMR)
Progression Free Survival (PFS)

Full Information

First Posted
June 16, 2020
Last Updated
May 18, 2023
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04440059
Brief Title
A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
Official Title
A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2019 (Actual)
Primary Completion Date
December 31, 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
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022. Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia 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
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICP-022
Arm Type
Experimental
Arm Description
Subjects will take ICP-022 150mg once daily (QD).
Intervention Type
Drug
Intervention Name(s)
ICP-022
Intervention Description
ICP-022 at a dose of 150mg PO QD
Primary Outcome Measure Information:
Title
Major response rate（MRR）
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
The 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 4.03 grading criteria
Time Frame
Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.
Title
Duration of Major Mitigation (DOMR)
Time Frame
Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.
Title
Progression Free Survival (PFS)
Time Frame
Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion criteria: Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003) At least one treatment indication is met (7th WM International Working Group standards, IWWM-7) (Dimopoulos et al., 2014) With the lowest serum IgM value >2 times ULN as the efficacy evaluation index ECOG physical strength score 0-2 Voluntary written informed consent prior to trial screening. Key Exclusion Criteria: Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years Amyloidosis and central nervous system (CNS) involvement caused by WM Demonstrate disease transformation Patients who had received autologous stem cell transplantation within the previous 6 months A history of organ transplantation or allogeneic bone marrow transplantation NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
West China hospital of sichuan university
City
Sichuan
State/Province
Chengdu
Country
China
Facility Name
Union Hospital affiliated to Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Henan Provincial Peoples's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tongji Hospital affiliated to Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Ruijin Hospital affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Hospital of Hematology, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Union Hospital affiliated to Huazhong University of Science and Technology
City
Hubei
State/Province
Wuhan
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36313145
Citation
Cao XX, Jin J, Fu CC, Yi SH, Zhao WL, Sun ZM, Yang W, Li DJ, Cui GH, Hu JD, Liu T, Song YP, Xu B, Zhu ZM, Xu W, Zhang MZ, Tian YM, Zhang B, Zhao RB, Zhou DB. Evaluation of orelabrutinib monotherapy in patients with relapsed or refractory Waldenstrom's macroglobulinemia in a single-arm, multicenter, open-label, phase 2 study. EClinicalMedicine. 2022 Oct 4;52:101682. doi: 10.1016/j.eclinm.2022.101682. eCollection 2022 Oct.
Results Reference
derived

Learn more about this trial

A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia

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