Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B Cell Lymphoma, Gene Mutation
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Qunling Zhang, PhD; Phone Number: 88900 +86-021-64175590; Email: zqldoc@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Qunling Zhang, PhD; Phone Number: 88900 +86-021-64175590; Email: zqldoc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all new diagnosed DLBCL

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
NGS Panel; patients who had NGS 481 gene mutation detected

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Anticipated): February 8, 2022
• Study Completion (Anticipated): February 8, 2024

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: gene abnormalities in DLBCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No