A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
NCT ID: NCT04440059
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2019-08-10
2024-01-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICP-022
Subjects will take ICP-022 150mg once daily (QD).
ICP-022
ICP-022 at a dose of 150mg PO QD
Interventions
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ICP-022
ICP-022 at a dose of 150mg PO QD
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
West China hospital of sichuan university
Sichuan, Chengdu, China
Union Hospital affiliated to Fujian Medical University
Fuzhou, Fujian, 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, China
Tongji Hospital affiliated to Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Ruijin Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Union Hospital affiliated to Huazhong University of Science and Technology
Hubei, Wuhan, China
The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
Countries
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References
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Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
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.
Other Identifiers
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ICP-CL-00105
Identifier Type: -
Identifier Source: org_study_id
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