Status:
UNKNOWN
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
PCNSL
Secondary Central Nervous System Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
Detailed Description
Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nerv...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04438044
Start Date
June 18 2019
End Date
December 31 2023
Last Update
October 12 2022
Active Locations (5)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
2
Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
3
Capital Medical University Xuanwu Hospital
Beijing, Beijing Municipality, China
4
Guangdong General Hospital
Guangzhou, Guangdong, China