Clinical trial · Interventional
New Genotype-guided Treatment in Newly Diagnosed PTCL
A New Genotype-guided Therapy in Newly Diagnosed Patients With Peripheral T-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma (PTCL) | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine plus Golidocitinib with CHOP | Drug | — | UNRESOLVED |
| Azacitidine plus Selinexor with CHOP | Drug | — | UNRESOLVED |
| CHOP | Drug | — | UNRESOLVED |
| Decitabine plus Selinexor with CHOP | Drug | — | UNRESOLVED |
| Zeprumetostat plus chidamide with CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Subgroup 1
- description
- TET2/RHOA co-mutated genetic subtype
- interventionNames
- Drug: Azacitidine plus Selinexor with CHOP
- Drug: CHOP
- type
- EXPERIMENTAL
- label
- Subgroup 2
- description
- TP53-mutated genetic subtype
- interventionNames
- Drug: Decitabine plus Selinexor with CHOP
- Drug: CHOP
- type
- EXPERIMENTAL
- label
- Subgroup 3
- description
- Core epigenetic genes-mutated genetic subtype
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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, 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 * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): Neutrophils\<1.5×10\^9/L Platelets\<75×10\^9/L (Neutrophils\<1.0×10\^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
References
Publications (0)
Data not yet available