UnknownPhase 2

A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL

China61 participantsStarted 2019-06-18

Plain-language summary

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

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

NCT IDNCT04438044

SponsorBeijing InnoCare Pharma Tech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-31