A Single-arm, Phase II Study to Evaluate the Efficacy and Safety of Linperlisib (YY-20394) Monotherapy in Patients with Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma

Conditions

Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma

Brief summary

Overall response rate (ORR = CR + PR) for PTCL, from start of treatment to first documented response, measured by Lugano 2014 Response Criteria for NHL (Cheson 2014) Overall response rate (ORR = CR + PR) for CTCL, from start of treatment to first documented response, based on Olsen Global Response Score (Olsen 2011)

Detailed description

DOR, defined as time from first documentation of a response (PR or CR) to the first documented disease progression or death due to any cause, whichever occurs first, for those patients with a PR or CR., PFS, defined as the time from start of treatment to first documented disease progression or death due to any cause, whichever occurs first. Overall survival (OS) Time to response (TTR), Incidence and severity of Adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Discontinuation of study treatment due to an AE, PK parameters include: AUClast, AUCinf, Cmin, Cmax, T1/2, and Tmax., Exploratory: to investigate correlations between protein biomarkers, immune cells, and gene mutations in PTCL or CTCL tumors and blood with response and survival

Related papers

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Interventions

DRUGLinperlisib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR = CR + PR) for PTCL, from start of treatment to first documented response, measured by Lugano 2014 Response Criteria for NHL (Cheson 2014) Overall response rate (ORR = CR + PR) for CTCL, from start of treatment to first documented response, based on Olsen Global Response Score (Olsen 2011)	—

Secondary

Measure	Time frame
DOR, defined as time from first documentation of a response (PR or CR) to the first documented disease progression or death due to any cause, whichever occurs first, for those patients with a PR or CR., PFS, defined as the time from start of treatment to first documented disease progression or death due to any cause, whichever occurs first. Overall survival (OS) Time to response (TTR), Incidence and severity of Adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Discontinuation of study treatment due to an AE, PK parameters include: AUClast, AUCinf, Cmin, Cmax, T1/2, and Tmax., Exploratory: to investigate correlations between protein biomarkers, immune cells, and gene mutations in PTCL or CTCL tumors and blood with response and survival	—

Measure

Time frame

DOR, defined as time from first documentation of a response (PR or CR) to the first documented disease progression or death due to any cause, whichever occurs first, for those patients with a PR or CR., PFS, defined as the time from start of treatment to first documented disease progression or death due to any cause, whichever occurs first. Overall survival (OS) Time to response (TTR), Incidence and severity of Adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Discontinuation of study treatment due to an AE, PK parameters include: AUClast, AUCinf, Cmin, Cmax, T1/2, and Tmax., Exploratory: to investigate correlations between protein biomarkers, immune cells, and gene mutations in PTCL or CTCL tumors and blood with response and survival

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Countries

Italy

Outcome results

None listed