Actively Recruiting
Genotype-guided Treatment in DLBCL
Led by Ruijin Hospital · Updated on 2023-03-24
1100
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Genotype-guided Treatment in DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diffuse large B-cell lymphoma without central nervous system involvement
- Availability of archival or freshly collected tumor tissue before study enrollment
- 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 of at least 6 months
- Written informed consent provided by the patient or legal representative prior to any special examination or procedure for the research
You will not qualify if you...
- Previous chemotherapy
- Previous stem cell transplantation
- History of other malignancies except 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, or other significant diseases
- Patients with central nervous system lymphoma
- Primary mediastinal large B-cell lymphoma
- Left ventricular ejection fraction less than 50%
- Neutrophils less than 1.5 x 10^9/L unless caused by lymphoma
- Platelets less than 75 x 10^9/L, or less than 50 x 10^9/L if bone marrow is involved
- ALT or AST levels more than twice the upper limit of normal, alkaline phosphatase and bilirubin more than 1.5 times the upper limit of normal
- Creatinine more than 1.5 times the upper limit of normal
- HIV infection
- Positive test for chronic hepatitis B or hepatitis C infection
- Psychiatric disorders or inability to fully comply with the study protocol
- Pregnancy or lactation
- Requirement for strong or moderate CYP3A inhibitors or inducers
- Inability to swallow capsules or gastrointestinal diseases significantly affecting absorption such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease, or intestinal obstruction
- Other medical conditions deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
P
Pengpeng Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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