Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

NCT ID: NCT04825899

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2024-02-08

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.

Conditions

Diffuse Large B Cell Lymphoma, Gene Mutation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

NGS Panel

patients who had NGS 481 gene mutation detected

Intervention Type: OTHER

Interventions

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Junning Cao, MD

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qunling Zhang, PhD

Role: CONTACT

zqldoc@163.com

+86-021-64175590 ext. 88900

Facility Contacts

Qunling Zhang, PhD

Role: primary

zqldoc@163.com

+86-021-64175590 ext. 88900

Other Identifiers

gene abnormalities in DLBCL

Identifier Type: -

Identifier Source: org_study_id