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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
R-PMDT
DrugRituximab (375 mg/m², IV infusion) is given on day 0; methotrexate (3.5 g/m², IV infusion over 3 hours) on day 1; dexamethasone (20 mg, IV infusion) on days 1-4; thiotepa (30 mg/m², IV infusion) on day 1; and pirtobrutinib (200 mg, oral) on days 4-21 or until the day prior to methotrexate administration in the next cycle.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: R-PMDTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
The proportion of subjects achieving either a complete response (CR) or partial response (PR) after treatment with R-PMDT, as assessed by the Lugano criteria.
Time frame
up to 2 yearsSecondary outcomes
1
Complete response rate (CRR)
The proportion of subjects achieving a CR after treatment with R-PMDT, as assessed by the Lugano criteria.
Time frame
up to 2 years2
Progression-Free-Survival (PFS)
From the date of the first dose of therapy is given until disease progression, death or last follow-up
Time frame
up to 2 years3
Overall survival (OS)
From the date of the first dose of therapy to the date of death from any cause.
Time frame
up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zou Dehui
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Sponsor institution
Source ClinicalTrials.gov