Clinical trial NCT04825899: Gene Abnormalities and Prognosis in Diffuse Large B-cell Lymphoma
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Large B Cell Lymphoma, Gene Mutation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all new diagnosed DLBCL

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.

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

Primary outcomes:
measure: the incidence of gene mutation in DLBCL
timeFrame: 3 years
measure: The incidence of gene mutation in different subtype of DLBCL
timeFrame: 3years
measure: The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: