YY-20394 for Peripheral T-Cell Lymphoma (Relapsed/Refractory)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Peripheral T-Cell Lymphoma (Relapsed/Refractory)YY-20394 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase II, single-arm study to evaluate the efficacy, safety, and PK of oral linperlisib (YY-20394) monotherapy in adult patients with R/R Peripheral T/NK Cell Lymphoma. The study will be conducted at approximately 15 sites in United States.

Eligible Conditions
  • Peripheral T-Cell Lymphoma (Relapsed/Refractory)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Throughout the study for approximately 2 years

Year 2
AE
AUCinf
AUClast
Cmax
Cmin
Overall survival (OS)
T1/2
Time to response (TTR)
Tmax
duration of response (DOR)
overall response rate (ORR)
progression-free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
Mogamulizumab
1
CD4CAR
1
lacutamab

Trial Design

1 Treatment Group

YY-20394
1 of 1

Experimental Treatment

97 Total Participants · 1 Treatment Group

Primary Treatment: YY-20394 · No Placebo Group · Phase 2

YY-20394
Drug
Experimental Group · 1 Intervention: YY-20394 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the study for approximately 2 years

Who is running the clinical trial?

Shanghai YingLi Pharmaceutical Co. Ltd.Lead Sponsor
15 Previous Clinical Trials
1,071 Total Patients Enrolled
Ranjit Nair, MD.Principal InvestigatorMD Anderson, Houston TX 77030 Study Chair: Swaminathan P Iyer MD

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have peripheral T-cell lymphoma
The tumor is a T-cell lymphoma.
You have ALK positive or ALK negative Anaplastic large cell lymphoma.
You have NK/T-cell lymphoma.
You have monomorphic epitheliotropic intestinal T-cell lymphoma.
You are not a candidate for autologous or allogeneic transplantation.
You agree to provide archived tumor tissue samples or undergo pretreatment fresh tissue biopsy.
References

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