Genotype-guided Treatment in DLBCL

Summary

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

Conditions2

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