Dynamic CtDNA-guided Targeted Therapy in DLBCL

Launched by RUIJIN HOSPITAL · Dec 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating patients with a type of lymphoma called Diffuse Large B Cell Lymphoma (DLBCL), specifically those who are newly diagnosed and have not received treatment before. The goal is to see how well targeted therapies, based on changes in a specific blood test called ctDNA after one round of chemotherapy, can work alongside the standard treatment regimen known as R-CHOP. The study will include 108 patients who will be monitored for safety and effectiveness over a two-year period.

To qualify for the trial, participants must be between 18 and 75 years old, have a specific type of DLBCL that tests positive for a marker called CD20, and have a certain score measuring the severity of their disease. Potential participants should be able to commit to the study procedures and have a life expectancy of at least six months. During the trial, those whose cancer shows a good response to the first treatment will continue with R-CHOP, while those who might not respond well will receive a different combination of targeted therapies tailored to their cancer's genetic profile. It’s important to note that individuals with certain health issues or previous cancer treatments may not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed Informed Consent Form
• • Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
• • Previously untreated participants with CD20-positive DLBCL
• • IPI score 2-5
• • ECOG Performance Status of 0, 1, or 2
• • Life expectancy ≥ 6 months
• Exclusion Criteria:
• • Contraindication to any of the individual components of R-CHOP or Obutinib or Decitabine or Lenalidomide or Chidamide
• • Have received systemic or local treatment including chemotherapy in the past
• • Have received autologous stem cell transplantation in the past
• • Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
• • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases
• • Primary central nervous system lymphoma
• • Left ventricular ejection fraction ≦50%
• • Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers' decision
• * Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
• • ANC \< 1.0 x 10\^9/L
• • PLT \< 75 x 10\^9/L
• • Hb \< 100g/L
• • Serum AST and ALT ≥ 2.5 x ULN
• • Total bilirubin ≥ 1.5 x ULN
• • Serum creatinine ≥ 1.5 x ULN
• • Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
• • Pregnant or lactating women
• • Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group
• • Patients living with HIV