Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

Overview

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, zqldoc@163.com

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