A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma

Обзор

This trial was a prospective, multicenter, randomized, controlled Phase III clinical design to compare the efficacy and safety of decitabine combined with R-CHOP (R-CHOP-D) versus R-CHOP in the treatment of primary EBV+ diffuse large B-cell lymphoma (DLBCL). Sixty patients were randomized 1:1 into R-CHOP-D (trial group) or R-CHOP (control group). The trial consisted of a screening period (days -28 to -1), a treatment period, and a follow-up period (2 years after the end of the last trial).

Вмешательства

• Препарат R-CHOP
  Decitabine in combination with R-CHOP
• Препарат Decitabine in combination with R-CHOP
  Decitabine in combination with R-CHOP

Первичные конечные точки

• 2-year progression-free survival [Срок оценки: 2 year]

Критерии участия

Критерии включения

• Initial treatment of diffuse large B-cell lymphoma (DLBCL) confirmed by tumor histopathology with at least one lesion on either axis More than 1.5 cm, sufficient specimens for second-generation sequencing or single-cell sequencing;
• Age > 18 years old, < 80 years old, gender unlimited;
• EBER+ or peripheral blood EBV-DNA of pathological specimen was greater than 103copy/ml;
• Patients judged by the investigator to have a life expectancy of at least 6 months;
• The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.
• Signed written informed consent before screening.

Критерии исключения

• Have previously received systemic or local treatment including chemotherapy;
• Previously received autologous stem cell transplantation;
• Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
• Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases and serious infectious diseases;
• Lymphoma involves the central nervous system;
• Primary mediastinal large B-cell lymphoma;
• Left ventricular ejection fraction < 50%;
• Laboratory test values at the time of screening: (unless due to lymphoma);

• Neutrophils < 1.5 x 109/L;
• Platelet < 75 x 109/L;
• ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal;
• creatinine levels higher than 1.5 times the upper limit of normal;
• Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
• Pregnant or lactating women;
• Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (polymerase chain Reaction \[PCR\] showed positive results). If the HbsAg test result is positive, HBV DNA test should be performed, if the HBV DNA<103IU/ml, can be enrolled. If HBsAg test results are negative, but HBcAb test is positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<103 IU/ml can be enrolled. If the patient's HCV antibody is positive, the HCV RNA is detected by PCR. If positive, the exclusion criteria are met.
• Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Nanchang University — Nanchang

Идентификаторы

NCT: NCT07348575 · BR/AF/SG-05/1.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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