Actively Recruiting
A Study to Evaluate Rituximab, Pirtobrutinib, High-Dose Methotrexate, Dexamethasone, and Thiotepa (R-PMDT) in Newly Diagnosed Primary Central Nervous System Lymphoma
Led by Zou Dehui · Updated on 2026-05-22
33
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying treatment for patients with newly diagnosed primary central nervous system lymphoma (PCNSL). This open-label, single-arm phase 2 trial aims to evaluate the overall response rate of a combination regimen called R-PMDT, which includes rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, and thiotepa. Secondary goals include assessing complete response rate, progression-free survival, overall survival, and safety of this treatment. Participants will receive six cycles of the R-PMDT regimen. Rituximab is given as an intravenous infusion on day 0; methotrexate as a 3-hour intravenous infusion on day 1 with dose adjustments based on kidney function; dexamethasone intravenously on days 1 to 4; thiotepa intravenously on day 1; and pirtobrutinib orally daily from days 4 to 21 or until the day before the next methotrexate dose. After six cycles, patients may receive additional consolidation or maintenance therapies, like stem cell transplantation, radiotherapy, or pirtobrutinib maintenance, as decided by the investigator. Throughout the study, participants will be closely monitored to assess response to treatment and safety. Researchers will evaluate outcomes such as overall response rate, complete response rate, progression-free survival, and overall survival for up to two years. The study involves regular clinical assessments, laboratory tests, and imaging as needed to track treatment effects and monitor patient health during and after the regimen.
CONDITIONS
Brief Title
R-PMDT Regimen in Newly Diagnosed PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed primary central nervous system diffuse large B-cell lymphoma
- Absolute neutrophil count of at least 1.0 x10⁹/L
- Platelet count of at least 75 x10⁹/L
- Liver enzymes ALT/AST no more than 3 times the upper limit of normal
- Total bilirubin no more than 1.5 times the upper limit of normal
- Serum creatinine no more than 2 times the upper limit of normal or creatinine clearance at least 40 mL/min
- Left ventricular ejection fraction of at least 55% by echocardiography
- Oxygen saturation greater than 92% on room air
- Expected survival of at least 3 months
You will not qualify if you...
- Prior anti-lymphoma therapy other than corticosteroids
- Uncontrolled significant cardiovascular or cerebrovascular disease
- Uncontrolled active bacterial, fungal, or viral infection
- Active hepatitis B or C infection (HCV RNA positive)
- Hypersensitivity to any study drug or its components
- Other active malignancy except controlled non-melanoma skin cancer, in situ carcinoma, or malignancy in remission for at least 5 years
- Pregnant or lactating women; fertile patients not willing to use effective contraception
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Six cycles with cycle length as per protocol
Participants receive six cycles of the R-PMDT regimen, which includes intravenous infusions of rituximab, methotrexate, dexamethasone, and thiotepa, along with oral pirtobrutinib daily during each cycle.
6 cycles of treatment visits including infusions and oral medication days
Duration - Up to 2 years
After completing six cycles, participants may receive additional consolidation or maintenance therapy such as stem cell transplantation, radiotherapy, or pirtobrutinib maintenance depending on the investigator's decision.
Periodic visits depending on consolidation or maintenance therapy
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 022
Actively Recruiting
Research Team
W
Wei Liu, Docter
D
Dehui Zou, Docter
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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