Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma


to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing and analyze the relationship between this gene abnormalities and the efficacy and prognosis in diffuse large B cell lymphoma.

Full Title of Study: “A Non-interventional Study on the Relationship Between Gene Abnormalities and the Efficacy and Prognosis in Patients With Diffuse Large B-cell Lymphoma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 8, 2022

Detailed Description

This is one arm, single center non-intervention study. New diagnosed diffuse large B cell lymphoma patients were enrolled to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing, then patients received standard treatment with R-CHOP, R2CHOP and DA-EPOCH by investigate's choice according to the patients pathological characteristics. the basic characteristics and treatment response and progression-free survival and overall survival were collected and analyzed with the gene abnormalities. a total of 100 diffuse large B cell lymphoma patients will enrolled in one year and will finish after 3 years.

Arms, Groups and Cohorts

  • NGS Panel
    • patients who had NGS 481 gene mutation detected

Clinical Trial Outcome Measures

Primary Measures

  • the incidence of gene mutation in DLBCL
    • Time Frame: 3 years
  • The incidence of gene mutation in different subtype of DLBCL
    • Time Frame: 3years
  • The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities
    • Time Frame: 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • ECOG PS 0-2; – histological diagnosed diffuse large B cell lymphoma; – normal hematological, hepatal, renal function; – normal heart function with LVEF ≥ 50%; Exclusion Criteria:

  • Diagnosed as a malignant tumor other than lymphoma or receiving treatment, except for the following conditions: ①Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred ≥5 years before enrollment; ②Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease; ③ Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease. – Heart disease with clinical significance, including unstable angina pectoris, acute myocardial infarction within 6 months before screening. – Congestive heart failure (NYHA) heart function is graded in grade III or IV (Annex 3) – Severe arrhythmia requiring treatment. – Patients with active hepatitis B and HIV infection. – Women who are pregnant or breastfeeding – Patients who have received organ transplants in the past – Patients with severe active infection – Have a history of severe neurological or psychiatric diseases, including dementia or epilepsy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Junning Cao, MD, Chief Physician – Fudan University
  • Overall Contact(s)
    • Qunling Zhang, PhD, +86-021-64175590,

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.