Genotype-guided treatment for diffuse large B-cell lymphoma
A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
PHASE3 · Ruijin Hospital · NCT05351346
This study is testing if using genetic information to guide treatment can help people with diffuse large B-cell lymphoma do better with their chemotherapy compared to the standard treatment.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Drugs / interventions | chemotherapy, rituximab, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05351346 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a genotype-guided approach using targeted agents combined with standard chemotherapy (R-CHOP-X) compared to the standard R-CHOP regimen in patients with diffuse large B-cell lymphoma (DLBCL). It is a multicenter, prospective, randomized, open-label, controlled trial designed to improve treatment outcomes by tailoring therapy based on genetic information. Participants will be monitored for efficacy and safety throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically-confirmed DLBCL who meet specific prognostic criteria and have adequate performance status.
Not a fit: Patients who have previously undergone chemotherapy or stem cell transplantation, or those with central nervous system involvement, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with diffuse large B-cell lymphoma.
How similar studies have performed: Other studies have shown promise in using genotype-guided approaches for cancer treatment, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement) * Availability of archival or freshly collected tumor tissue before study enrolment * International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Life expectancy greater than or equal to (\>/=) 6 months * The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research Exclusion Criteria: * Previous chemotherapy. * Previous stem cell transplantation. * 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 * Patients with central nervous system (CNS) lymphoma * Primary mediastinal large B-cell lymphoma * Left ventricular ejection fraction\<50% * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): 1. Neutrophils\<1.5×10\^9/L 2. Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) 3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN. 4. Creatinine is 1.5 times higher than the ULN. * HIV-infected patients * Positive test results for chronic hepatitis B and hepatitis C 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 * Require treatment with strong/moderate CYP3A inhibitors or inducers. * Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction * Other medical conditions determined by the researchers that may affect the study
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — 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.
Conditions: Diffuse Large B Cell Lymphoma