R-PMDT Regimen in Newly Diagnosed PCNSL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZou Dehui
About this trial
A total of six cycles of the R-PMDT regimen (rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, and thiotepa) will be administered to patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluating the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.
Eligibility criteria
Qualifiers
Newly diagnosed primary central nervous system diffuse large B-cell lymphoma
Adequate hematologic function: ANC ≥1.0×10⁹/L, PLT ≥75×10⁹/L
Adequate hepatic function: ALT/AST ≤3×ULN; total bilirubin ≤1.5×ULN
Adequate renal function: serum creatinine ≤2×ULN or CrCl ≥40 mL/min
Disqualifiers
Prior anti-lymphoma therapy other than corticosteroids.
Uncontrolled significant cardiovascular or cerebrovascular disease.
Uncontrolled active systemic bacterial, fungal, or viral infection.
Active hepatitis B and/or active hepatitis C (HCV RNA positive). Patients with positive hepatitis B surface antigen and/or core antibody but HBV-DNA < 1000 IU/mL may be included and should receive concurrent oral antiviral prophylaxis against HBV reactivation.
Trial design
Treatments tested in this trial
- R-PMDT
Treatment groups
33 Participants
are divided into 1 treatment groupSponsors and collaborators
Zou Dehui
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Sponsor institution
Source ClinicalTrials.gov