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โ† Trials
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Genotype-guided Treatment in Newly Diagnosed PTCL

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllRuijin Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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\<1.0ร—10\^9/L Platelets\<75ร—10\^9/L (Platelets\<50ร—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
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What it tests

  • CHOP+selinexor+5-Azacitidine
  • CHOP+duvelisib+5-Azacitidine
  • CHOP+chidamide+tislelizumab
  • standard CHOP
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Where

1 site
Ruijin hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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