Clinical trial NCT04440059: A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia
Official title: A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Waldenstrom's Macroglobulinemia Recurrent
Waldenstrom's Macroglobulinemia Refractory
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major response rate（MRR）
timeFrame: Up to 3 years
Secondary outcomes:
measure: The occurrence of adverse events and serious adverse events
timeFrame: Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.
measure: Duration of Major Mitigation (DOMR)
timeFrame: 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.
measure: Progression Free Survival (PFS)
timeFrame: 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.
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Sichuan
country: China
facility: West China hospital of sichuan university
state: Chengdu
city: Fuzhou
country: China
facility: Union Hospital affiliated to Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial Peoples's Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Tianjin
country: China
facility: Hospital of Hematology, Chinese Academy of Medical Sciences
state: Tianjin
city: Hubei
country: China
facility: Union Hospital affiliated to Huazhong University of Science and Technology
state: Wuhan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
References:
citation: 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.