NCT05675813 Genotype-guided Treatment in Newly Diagnosed PTCL
| NCT ID | NCT05675813 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Peripheral T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2023-02-13 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 264 participants in total. It began in 2023-02-13 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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\<1.0×10\^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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05675813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Peripheral T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05675813 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05675813 currently recruiting?
Yes, NCT05675813 is actively recruiting participants. Contact the research team at zwl_trial@163.com for enrollment information.
Where is the NCT05675813 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05675813 clinical trial?
NCT05675813 is sponsored by Ruijin Hospital. The trial plans to enroll 264 participants.