A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL
A Phase II, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Recurrent/Refractory Central Nervous System Lymphoma and Recurrent/Refractory Secondary Central Nervous System Lymphoma
1 other identifier
interventional
61
1 country
5
Brief Summary
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2019
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2019
CompletedFirst Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 12, 2022
October 1, 2022
4.5 years
June 16, 2020
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The efficacy measured by overall response rate (ORR)
Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
Secondary Outcomes (3)
The occurrence of adverse events and serious adverse events
every cycle, first cycle every week. Each cycle is 28 days
The efficacy measured by progression free survival (PFS)
cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
The efficacy measured by duration of response (DOR)
cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days
Study Arms (1)
ICP-022
EXPERIMENTAL150mg,QD
Interventions
Eligibility Criteria
You may qualify if:
- Men and women ≥ 18, and ≤75 years of age
- Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL.
- Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments.
- ECOG performance status of 0-2
- Able to provide signed written informed consent
You may not qualify if:
- Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded
- T-cell lymphoma.
- Patient requires more than 8 mg of dexamethasone daily or the equivalent.
- Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia)
- Known active infection with HBV, HCV or HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Capital Medical University Xuanwu Hospital
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 18, 2020
Study Start
June 18, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share