A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)
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.
Major response rate（MRR）
The occurrence of adverse events and serious adverse events
Waldenstrom's Macroglobulinemia Recurrent
Study Arms / Comparison Groups
Description: Subjects will take ICP-022 150mg once daily (QD).
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
July 11, 2019
December 31, 2023
Primary Completion Date
December 31, 2023
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.
18 Years - N/A
Accepts Healthy Volunteers
Beijing InnoCare Pharma Tech Co., Ltd.