A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
- Conditions
- Waldenstrom's Macroglobulinemia RecurrentWaldenstrom's Macroglobulinemia Refractory
- Interventions
- Registration Number
- NCT04440059
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-022 ICP-022 Subjects will take ICP-022 150mg once daily (QD).
- Primary Outcome Measures
Name Time Method Major response rateοΌMRRοΌ Up to 3 years
- Secondary Outcome Measures
Name Time Method 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. The occurrence of adverse events and serious adverse events Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days. 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) 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.
Trial Locations
- Locations (16)
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
π¨π³Hefei, Anhui, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
π¨π³Beijing, Beijing, China
Union Hospital affiliated to Fujian Medical University
π¨π³Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
π¨π³Xiamen, Fujian, China
First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
Henan Provincial Peoples's Hospital
π¨π³Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University
π¨π³Suzhou, Jiangsu, China
Union Hospital affiliated to Huazhong University of Science and Technology
π¨π³Hubei, Wuhan, China
Tongji Hospital affiliated to Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Hospital of Hematology, Chinese Academy of Medical Sciences
π¨π³Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University Medical College
π¨π³Hangzhou, Zhejiang, China
Jiangsu Province Hospital
π¨π³Nanjing, Jiangsu, China
West China hospital of sichuan university
π¨π³Sichuan, Chengdu, China
Shengjing Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Ruijin Hospital affiliated to Shanghai Jiao Tong University
π¨π³Shanghai, Shanghai, China