A Prospective, Multicenter, Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Rituximab, Pirtobrutinib, High-Dose Methotrexate, Dexamethasone, and Thiotepa (R-PMDT) in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
Sponsor study identifier
interventional
33
1 country
1
Study Start
May 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2026
Actual (reported)May 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 22, 2026
Actual (reported)May 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
up to 2 years
Complete response rate (CRR)
up to 2 years
Progression-Free-Survival (PFS)
up to 2 years
Overall survival (OS)
up to 2 years
Eligible patients will receive six cycles of the R-PMDT regimen.
Rituximab (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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Institute of Hematology & Blood Diseases Hospital
Tianjin, 022, China
Dehui Zou, Docter
CONTACT
First Submitted
May 17, 2026
First Posted
May 22, 2026
Study Start
May 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 20, 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 22, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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