Genotype-guided treatment for newly diagnosed peripheral T-cell lymphoma
Guidance-04：T-cell Lymphoma Series：A Genotype-guided Therapy in Newly Diagnosed Patients With Peripheral T-cell Lymphoma （THEORY Study）
This study is testing if using genetic information to guide treatment can help people with newly diagnosed peripheral T-cell lymphoma respond better to standard chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | cyclophosphamide, doxorubicin, prednisone, Brentuximab, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05675813 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically-confirmed peripheral T-cell lymphoma who can provide tumor tissue for genetic analysis.
Not a fit: Patients with anaplastic large cell lymphoma (ALCL), central nervous system lymphoma, or those with uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance treatment outcomes for patients with peripheral T-cell lymphoma by personalizing therapy based on genetic profiles.
How similar studies have performed: Previous studies have shown promise in using genotype-guided approaches in similar contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weili Zhao
- Email: zwl_trial@163.com
- Phone: +862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.