OncoMatch/Clinical Trials/NCT05675813
Genotype-guided Treatment in Newly Diagnosed PTCL
Official title: Guidance-04：T-cell Lymphoma Series：A Genotype-guided Therapy in Newly Diagnosed Patients With Peripheral T-cell Lymphoma （THEORY Study）
Is NCT05675813 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including CHOP+selinexor+5-Azacitidine and CHOP+duvelisib+5-Azacitidine for peripheral t cell lymphoma.
Treatment: CHOP+selinexor+5-Azacitidine · CHOP+duvelisib+5-Azacitidine · CHOP+chidamide+tislelizumab · standard CHOP — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Lab requirements
Blood counts
Neutrophils ≥ 1.0×10^9/L; Platelets ≥ 75×10^9/L (≥ 50×10^9/L if bone marrow involvement)
Kidney function
Creatinine ≤ 1.5x ULN
Liver function
ALT or AST ≤ 2.5x ULN; AKP and bilirubin ≤ 1.5x ULN
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05675813 currently recruiting?
Yes, this trial is currently recruiting patients.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages