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Not Yet Recruiting
NCT05675813
Genotype-guided Treatment in PTCL
Conditions: Peripheral T Cell Lymphoma
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE1, PHASE2
Enrollment: 264
Sponsor: Ruijin Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria:Histologically-confirmed Peripheral T-cell lymphomaAvailability of archival or freshly collected tumor tissue before study enrollmentEvaluable lesion by PET-CT or CT scanEastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2Life expectancy greater than or equal to (>/=) 3 monthsInformed consentExclusion Criteria:Patients with central nervous system (CNS) lymphomaHistory of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervixUncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseasesLaboratory 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 patientsActive hepatitis infectionPatients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocolPregnant or lactationOther medical conditions determined by the researchers that may affect the study For T3 should exclude patiens with active autoimmune disease
Source: ClinicalTrials.gov (NCT05675813). StuddyBuddy aggregates publicly available trial information.