Skip to content
TrialMatch
Sign up
Recruiting Phase 1 / Phase 2

Genotype-guided Treatment in Newly Diagnosed PTCL

Create a profile to match View the full record on ClinicalTrials.gov

About this study

This study includes Phase I and Phase II stages. Phase I is an open-label trial to confirm RP2D of oral targeted agents in three genetic subtypes. Phase II is a multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.

Condition
Peripheral T Cell Lymphoma
Tested
CHOP+selinexor+5-Azacitidine, CHOP+duvelisib+5-Azacitidine, CHOP+chidamide+tislelizumab, standard CHOP
Sponsor
Ruijin Hospital

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Peripheral T Cell Lymphoma
  • Histologically-confirmed Peripheral T-cell lymphoma
  • Availability of archival or freshly collected tumor tissue before study enrollment enough for NGS
  • Evaluable lesion by PET-CT or CT scan
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Life expectancy greater than or equal to (\>/=) 3 months
  • Informed consent

Exclusion 12

  • Patients with ALCL and cutaneous TCL
  • Patients with central nervous system (CNS) lymphoma
  • History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
  • Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
  • Neutrophils\<1.0×10\^9/L Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
  • Creatinine is 1.5 times higher than the ULN.
  • HIV-infected patients
  • Active hepatitis infection
  • Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
  • Pregnant or lactation
  • Other medical conditions determined by the researchers that may affect the study For T3 should exclude patiens with active autoimmune disease

Where

1 site, 1 recruiting

Ruijin hospital

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.