NCT06748521Not yet recruitingPhase 2
Dynamic CtDNA-guided Targeted Therapy in DLBCL
Efficacy and Safety of Dynamic CtDNA-guided Targeted Therapy in Patients with Previously Untreated Diffuse Large B-cell Lymphoma
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, single-arm, noninferiority trial involving patients with previously untreated CD20-positive DLBCL. The aim of this study is to determine the efficacy and safety of treatment stratified based on ctDNA dynamic changes after one cycle of chemotherapy and the targeted therapy based on DLBCL genotype. A total of 108 patients were planned to be enrolled in this trial, and the patients were stratified according to the dynamic changes of ctDNA after one cycle of chemotherapy: the chemotherapy-sensitive group continued the original R-CHOP regimen, and the potential drug resistance group received genotype-guided targeted drug combination. The whole trial included a screening period (day -28 to day -1), a treatment period, and a 2-year follow-up period.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 31 Dec 2024
- Primary completion date
- 13 Dec 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06748521
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 108
- From 31 Dec 2024 to the primary completion date, 13 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received systemic or local treatment including chemotherapy in the past
- Have received autologous stem cell transplantation in the past
- Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers' decision
Other illness
- 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
- Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
- 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
Lab values
- Left ventricular ejection fraction ≦50%
- 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
Other
- Contraindication to any of the individual components of R-CHOP or Obutinib or Decitabine or Lenalidomide or Chidamide
- Primary central nervous system lymphoma
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.