Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients
ConditionCNS Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-80
SponsorRuijin Hospital
About this trial
This study is designed as an open-label, prospective, single-arm, single-center trial aimed at evaluating the efficacy and safety of MTX or Thiotepa combined with Orelabrutinib and standard chemotherapy regimens in the treatment of DLBCL patients with central nervous system involvement.
Eligibility criteria
Qualifiers
Fully understand the study and voluntarily sign the informed consent form.
Age: 14-80 years.
Expected survival of more than 3 months, as determined by the investigator.
Pathologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL) of B-cell origin through pathology or flow cytometry.
Disqualifiers
Contraindications to any of the drugs included in the treatment regimen.
History of active liver disease, including viral or other hepatitis or liver cirrhosis (Hepatitis B is defined as HBV-DNA exceeding the upper limit of normal; active Hepatitis C is defined as seropositive for HCV antibodies, but patients with HCV-RNA negative results can be included).
Human immunodeficiency virus (HIV) infection.
Congestive heart failure classified as greater than NYHA Class II by the New York Heart Association; history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past six months.
Trial design
Treatments tested in this trial
- Orelabrutinib
- RCHOP+MTX or Thiotepa
Treatment groups
23 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov