Genotype-guided Treatment in DLBCL
A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
Ruijin Hospital
1,100 participants
Jun 1, 2022
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria19
- 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):
- Neutrophils\<1.5×10\^9/L
- Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement)
- 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.
- 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
Interventions
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone PO will be administered as per the schedule specified in the respective arm.
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05351346