Not Yet RecruitingNot Applicable

Mechanism Investigation of R-CHOP Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2/MYC Protein Double Expressor Lymphoma

400 participantsStarted 2024-10-30

Plain-language summary

This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓.At least one positive lesion according to the Lugano Classification by fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography(CT).
✓.Lymphoma International PrognosisIndex (IPI) score of 2,3,4. 6.Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2. 7.Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):
✓.Expected survival≥6 months. 9.All patients must have signed an informed consent document.

Exclusion criteria

✕3.Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.
✕4.Have uncontrolled or significant cardiovascular disease, including: Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \< 50% during screening stage.
✕5.History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.
✕6.Patients with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.
✕7.History of deep vein thrombosis or pulmonary embolism. 18.History of active bleeding within 2 months prior to the start of Cycle 1;or patients receiving anticoagulation therapy; or patients with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). Patients with bleeding led by lymphoma according to investigators' judgment are eligible.
✕9.6 weeks or less from the last major surgery that involved crucial organs, or with any other factors impede postoperative recovery according to investigators' judgment.
✕0.Known active infection, or active and uncontrolled hepatitis B infection(HBV), hepatitis C Virus(HCV), human immunodeficiency virus (HIV)/AIDS (Acquired Immune Deficiency Syndrome), or any other serious infection. (active infection defined as any major episode of infection requiring systemic treatment; Patients with occult or prior HBV may be included if HBV DNA is undetectable.) 21.Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements/ treatment.
✕2.Drug or alcohol abuse. 23.Women of childbearing potential and men who are sexually active not willing to practice a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.These restrictions apply for 12 months after the last dose of rituximab or 12 weeks after the last dose of study drug, whichever is later. Pregnancy or lactation.

What they're measuring

Event Free Survival (EFS)

Timeframe: Up to approximately 5 years

Trial details

NCT IDNCT06652152

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-30

Contact for this trial

Weili Zhao

+862164370045 zwl_trial@163.com

View on ClinicalTrials.gov More Diffuse Large B Cell Lymphoma (DLBCL) trials