A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL
NCT ID: NCT04438044
Last Updated: 2022-10-12
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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UNKNOWN
PHASE2
61 participants
INTERVENTIONAL
2019-06-18
2023-12-31
Brief Summary
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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
150mg,QD
ICP-022
ICP-022 The drug product is a white, round, uncoated tablet
Interventions
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ICP-022
ICP-022 The drug product is a white, round, uncoated tablet
Eligibility Criteria
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Inclusion Criteria
2. Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL.
3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments.
4. ECOG performance status of 0-2
5. Able to provide signed written informed consent
Exclusion Criteria
2. T-cell lymphoma.
3. Patient requires more than 8 mg of dexamethasone daily or the equivalent.
4. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia)
5. Known active infection with HBV, HCV or HIV.
18 Years
75 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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Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
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
Countries
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Other Identifiers
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ICP-CL-00106
Identifier Type: -
Identifier Source: org_study_id
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