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Search / Trial NCT06901999

Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients

Launched by RUIJIN HOSPITAL · Mar 28, 2025

Trial Information

Current as of April 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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:
  • 1. Symptoms related to CNS involvement.
  • 2. Abnormal findings on imaging.
  • 3. 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:
  • 1. Total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN if liver metastasis is present).
  • 2. 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 Criteria:
  • 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.

About Ruijin Hospital

Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, is a leading medical institution in China recognized for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, Ruijin Hospital integrates cutting-edge medical practices with rigorous scientific investigation. The hospital's multidisciplinary teams are dedicated to developing new therapeutic approaches, improving patient outcomes, and contributing to global medical knowledge. As a sponsor of clinical trials, Ruijin Hospital ensures adherence to the highest ethical standards and regulatory compliance, fostering an environment of collaboration and excellence in clinical research.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported