Overview

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

Eligibility

Inclusion Criteria:

• Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
• Availability of archival or freshly collected tumor tissue before study enrolment
• International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Life expectancy greater than or equal to (>/=) 6 months
• The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research

Exclusion Criteria:

• Previous chemotherapy.
• Previous stem cell transplantation.
• History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
• Patients with central nervous system (CNS) lymphoma
• Primary mediastinal large B-cell lymphoma
• Left ventricular ejection fraction<50%
• Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
  1. Neutrophils<1.5×10^9/L
  2. Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
  3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
  4. Creatinine is 1.5 times higher than the ULN.
• HIV-infected patients
• Positive test results for chronic hepatitis B and hepatitis C infection
• Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
• Pregnant or lactation
• Require treatment with strong/moderate CYP3A inhibitors or inducers.
• Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
• Other medical conditions determined by the researchers that may affect the study