Status:
UNKNOWN
Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma
Lead Sponsor:
Fudan University
Conditions:
Diffuse Large B Cell Lymphoma, Gene Mutation
Eligibility:
All Genders
18+ years
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 prog...
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 mut...
Eligibility Criteria
Inclusion
- ECOG PS 0-2;
- histological diagnosed diffuse large B cell lymphoma;
- normal hematological, hepatal, renal function;
- normal heart function with LVEF ≥ 50%;
Exclusion
- 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
Key Trial Info
Start Date :
March 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 8 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04825899
Start Date
March 8 2021
End Date
February 8 2024
Last Update
April 1 2021
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032