Linperlisib Combined With Chidamide in Patients With PTCL

The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL). The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients. The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.

Trial Details

NCT ID
NCT06421948
Phase
PHASE1 / PHASE2
Sponsor
Yanyan Liu
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Linperlisib and chidamide
  • cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
Locations (sample)
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Wuhan, Hubei, China|30.58333,114.26667
  • Changsha, Hunan, China|28.19874,112.97087
  • Chengdu, Sichuan, China|30.66667,104.06667
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study)
  • Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anap…
  • ECOG PS 0-2 at protocol entry
  • Estimated life expectancy of 6 months or longer

For full eligibility, visit ClinicalTrials.gov.

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