New Genotype-guided Treatment in Newly Diagnosed PTCL (NCT07706959) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
New Genotype-guided Treatment in Newly Diagnosed PTCL
China108 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended Phase 2 Dose (RP2D) for Phase I
Timeframe: Dose Limiting Toxicity (DLT) time window (28 days from Cycle 2)
2
Complete response rate (CRR) for Phase II
Timeframe: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])