Status:
COMPLETED
A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Waldenstrom's Macroglobulinemia Recurrent
Waldenstrom's Macroglobulinemia Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patient...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04440059
Start Date
August 10 2019
End Date
January 9 2024
Last Update
April 18 2024
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
2
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000
3
West China hospital of sichuan university
Sichuan, Chengdu, China
4
Union Hospital affiliated to Fujian Medical University
Fuzhou, Fujian, China