Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

Diffuse Large B Cell Lymphoma, Gene Mutation Clinical Trial

Official title:

A Non-interventional Study on the Relationship Between Gene Abnormalities and the Efficacy and Prognosis in Patients With Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04825899
• Other study ID #: gene abnormalities in DLBCL
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: February 8, 2024

Study information

• Verified date: March 2021
• Source: Fudan University
• Contact: Qunling Zhang, PhD
• Phone: +86-021-64175590
• Email: zqldoc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

?Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred =5 years before enrollment;

?Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease;

? 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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma, Gene Mutation
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of gene mutation in DLBCL		3 years
Primary	The incidence of gene mutation in different subtype of DLBCL		3years
Primary	The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities		3 years