Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

• Conditions: Diffuse Large B Cell Lymphoma, Gene Mutation

• Registration Number: NCT04825899
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-08
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Last Update Submitted: 2021-03-29
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Primary Completion: 2022-02-08
• Study Completion: 2024-02-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China