Status:
NOT_YET_RECRUITING
Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients
Lead Sponsor:
Ruijin Hospital
Conditions:
CNS Lymphoma
Eligibility:
All Genders
14-80 years
Phase:
PHASE2
Brief Summary
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 chemothera...
Eligibility Criteria
Inclusion
- 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.
- Central nervous system (CNS) involvement, confirmed by at least one of the following:
- Symptoms related to CNS involvement.
- Abnormal findings on imaging.
- Pathological evidence (positive cerebrospinal fluid cytology, positive brain lesion biopsy or positive cerebrospinal fluid ctDNA).
- Any non-hematologic toxicity related to prior treatments must have resolved to Grade 1 or normal levels (per NCI CTCAE Version 5.0), except for alopecia.
- Bone marrow and organ function must meet the following criteria (without blood transfusion, G-CSF administration, or pharmacological correction within 14 days prior to screening):
- Bone marrow function:
- 1)Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L. 2)Platelet count ≥ 50 × 10⁹/L. 3)Hemoglobin ≥ 60 g/L.
- Liver function:
- Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN if liver metastasis is present).
- AST and ALT ≤ 2.5 × ULN (≤ 5.0 × ULN if liver metastasis is present).
- Coagulation function:
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- • Renal function: Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula): Male: Cr (mL/min) = (140 - age) × weight (kg) / \[72 × serum creatinine (mg/dL)\]. Female: Cr (mL/min) = (140 - age) × weight (kg) / \[85 × serum creatinine (mg/dL)\].
- Women of childbearing potential (WOCBP) and men with reproductive potential must agree to use effective contraception during the study and for 3 months after discontinuing treatment.
- Good compliance, with willingness to adhere to visit schedules, dosing regimens, laboratory tests, and other study procedures.-
Exclusion
- 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.
- Congenital long QT syndrome or QTc \> 480 ms (Note: QTc must be calculated using Friederica's formula: QTcF = QT / (RR)\^0.33).
- Pregnant or breastfeeding women, or those planning to become pregnant during the study.
- History of confirmed neurological or psychiatric disorders, or a history of substance abuse or drug addiction.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06901999
Start Date
April 1 2025
End Date
November 1 2028
Last Update
March 30 2025
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