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

Waldenstrom's Macroglobulinemia Recurrent Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440059
• Other study ID #: ICP-CL-00105
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2019
• Est. completion date: January 9, 2024

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia Recurrent
• Waldenstrom's Macroglobulinemia Refractory

Intervention

Drug:
• ICP-022
ICP-022 at a dose of 150mg PO QD

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Union Hospital affiliated to Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang
China	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei	Anhui
China	Union Hospital affiliated to Huazhong University of Science and Technology	Hubei	Wuhan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Ruijin Hospital affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	West China hospital of sichuan university	Sichuan	Chengdu
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Hospital of Hematology, Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Tongji Hospital affiliated to Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Provincial Peoples's Hospital	Zhengzhou	Henan

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	Major response rate(MRR)		Up to 3 years
Secondary	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	Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.
Secondary	Duration of Major Mitigation (DOMR)		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.
Secondary	Progression Free Survival (PFS)		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.