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Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04825899
Collaborator
(none)
100
Enrollment
1
Location
35.1
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Mar 8, 2021
    Anticipated Primary Completion Date :
    Feb 8, 2022
    Anticipated Study Completion Date :
    Feb 8, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    NGS Panel

    patients who had NGS 481 gene mutation detected

    Outcome Measures

    Primary Outcome Measures

    1. the incidence of gene mutation in DLBCL [3 years]

    2. The incidence of gene mutation in different subtype of DLBCL [3years]

    3. The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Junning Cao, MD, Chief Physician, Fudan University
    ClinicalTrials.gov Identifier:
    NCT04825899
    Other Study ID Numbers:
    • gene abnormalities in DLBCL
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse

    Study Results

    No Results Posted as of Apr 1, 2021