Genotype-guided treatment for newly diagnosed peripheral T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of genotype-guided targeted therapies combined with standard chemotherapy (CHOP) in patients with newly diagnosed peripheral T-cell lymphoma (PTCL). It consists of two phases: Phase I focuses on determining the recommended phase 2 dose (RP2D) of oral targeted agents through a dose escalation method, while Phase II is a randomized controlled trial comparing the genotype-guided treatment (CHOP-X2) to standard CHOP. Patients will receive standard CHOP for the first cycle, followed by genetic testing to tailor subsequent treatment based on tumor characteristics. The goal is to improve response rates and overall survival in this challenging patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Ruijin hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Weili Zhao
• Email: zwl_trial@163.com
• Phone: +862164370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment options for peripheral T‑cell lymphoma after no response to first‑line therapy

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• Golidocitinib versus placebo as maintenance treatment for PTCL patients in remission after first-line chemotherapy

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• Cidabenamine plus azacitidine to prevent post-transplant progression in high-risk peripheral T‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.