New Genotype-guided Treatment in Newly Diagnosed PTCL
ConditionPeripheral T-cell Lymphoma (PTCL)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
This is a phase I/II study evaluate the safety and efficacy targeted agents in combination with standard CHOP in new genotypic subtypes in treatment naive peripheral T-cell lymphoma. Phase I is to confirm RP2D of targeted agent. Phase II is a multicenter, prospective, randomized, open-label, controlled design to evaluate the efficacy and safety of new 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
Qualifiers
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
Disqualifiers
Patients with ALCL and cutaneous TCL, MEITL, HSTCL, T-PLL, etc.
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
Trial design
Treatments tested in this trial
- Azacitidine plus Selinexor with CHOP
- Decitabine plus Selinexor with CHOP
- Zeprumetostat plus chidamide with CHOP
- Azacitidine plus Golidocitinib with CHOP
- CHOP
Treatment groups
108 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov