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Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

Recruiting
18 years of age
Both
Phase N/A

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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.

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.

Eligibility

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

Study details

Diffuse Large B Cell Lymphoma, Gene Mutation

NCT04825899

Fudan University

25 January 2024

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