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)
1 other identifier
interventional
47
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2019
Typical duration for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2019
CompletedFirst Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2024
CompletedApril 18, 2024
April 1, 2024
4.4 years
June 16, 2020
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Major response rate（MRR）
Up to 3 years
Secondary Outcomes (3)
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.
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.
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.
Study Arms (1)
ICP-022
EXPERIMENTALSubjects will take ICP-022 150mg once daily (QD).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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, 100000, 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
Related Publications (2)
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.
PMID: 39563886DERIVEDCao 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.
PMID: 36313145DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 19, 2020
Study Start
August 10, 2019
Primary Completion
January 9, 2024
Study Completion
January 9, 2024
Last Updated
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share