Status:
RECRUITING
Genotype-guided Treatment in DLBCL
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
West China Hospital, Sichuan
Qilu Hospital of Shandong University
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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, a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT05351346
Start Date
June 1 2022
End Date
June 1 2026
Last Update
March 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025