Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

Fudan University

Status: Unknown

Conditions: Diffuse Large B Cell Lymphoma, Gene Mutation

Study type: Observational

Funder types: Other

Identifiers

NCT04825899

gene abnormalities in DLBCL

Details and patient eligibility

About

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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

NGS Panel

Description:

patients who had NGS 481 gene mutation detected