Clinical trial NCT04438044: A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: PCNSL
Secondary Central Nervous System Lymphoma
Keywords: Recurrent or refractory
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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.

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 Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .

Eligibility criteria: Key Inclusion Criteria:

1. Men and women ≥ 18, and ≤75 years of age
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

Key Exclusion Criteria:

1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded
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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: The efficacy measured by overall response rate (ORR)
timeFrame: Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
Secondary outcomes:
measure: The occurrence of adverse events and serious adverse events
timeFrame: every cycle, first cycle every week. Each cycle is 28 days
measure: The efficacy measured by progression free survival (PFS)
timeFrame: cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
measure: The efficacy measured by duration of response (DOR)
timeFrame: cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Capital Medical University Xuanwu Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
References: