Diffuse Large B Cell Lymphoma, Gene Mutation
Conditions
Brief summary
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.
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.
Interventions
None listed
Sponsors
Fudan University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of gene mutation in DLBCL | 3 years |
| The incidence of gene mutation in different subtype of DLBCL | 3years |
| The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities | 3 years |
Countries
China
Contacts
Primary ContactQunling Zhang, PhD
Outcome results
None listed