Primary Central Nervous System (CNS) LymphomaPhase 2NCT07604987
R-PMDT Regimen in Newly Diagnosed PCNSL
A Phase 2 study testing R-PMDT in people with Primary Central Nervous System (CNS) Lymphoma, run by Zou Dehui at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System (CNS) Lymphoma
- What is being tested?
- R-PMDT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- LVEF ≥55% by echocardiography
- Baseline oxygen saturation >92% on room air
- Expected survival ≥3 months
Who cannot join
- 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.
- Hypersensitivity to any study drug or its components.
- Other active malignancy, except for adequately controlled non-melanoma skin cancer, in situ carcinoma, or malignancy that has been in complete remission for ≥5 years.
- Pregnant or lactating women. Fertile patients unwilling to use effective contraception.
- Other conditions deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dehui Zou, Docter contact
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, 022
Shuo Chen, 022-23909095, ec@ihcams.ac.cn
About this study
Official title: 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
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.
Read the detailed description
In this prospective, multicenter, open-label, single-arm phase 2 clinical trial, eligible patients with newly diagnosed primary central nervous system lymphoma (PCNSL) will receive six cycles of the R-PMDT regimen. The R-PMDT regimen is administered as follows: rituximab (R, 375 mg/m²) is given as an intravenous infusion on day 0; methotrexate (M, 3.5 g/m²) is administered as a 3-hour intravenous infusion on day 1, with dose adjustment based on pre-treatment creatinine clearance; dexamethasone (D, 20 mg) is given intravenously on days 1-4; thiotepa (T, 30 mg/m²) is administered intravenously on day 1; and pirtobrutinib (P, 200 mg once daily) is taken orally on days 4-21. After completion of six cycles, depending on the investigator's decision, patients may receive consolidation or maintenance therapy, including but not limited to autologous hematopoietic stem cell transplantation, radiotherapy, or pirtobrutinib maintenance. The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluation of the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.
- Being tested
- R-PMDT
- Keywords
- R-PMDT, PCNSL
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-PMDTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| R-PMDT | Experimental | Eligible patients will receive six cycles of the R-PMDT regimen. Receives: Drug: R-PMDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years
Secondary outcomes (3)
Complete response rate (CRR)
The proportion of subjects achieving a CR after treatment with R-PMDT, as assessed by the Lugano criteria.
Measured: up to 2 years
Progression-Free-Survival (PFS)
From the date of the first dose of therapy is given until disease progression, death or last follow-up
Measured: up to 2 years
Overall survival (OS)
From the date of the first dose of therapy to the date of death from any cause.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start20 May 2026 (estimated)
- Primary completion20 May 2028 (estimated)
- Study completion20 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System (CNS) LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zou Dehui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zou Dehui, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604987
- Sponsor's protocol ID
- LBCL-RPMDT1.0
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07604987
- Acronym / sponsor ID
- LBCL-RPMDT1.0
- Keywords
- R-PMDT, PCNSL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Zou DehuiUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 May 2028 (estimated)
- Study completion
- 20 May 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this prospective, multicenter, open-label, single-arm phase 2 clinical trial, eligible patients with newly diagnosed primary central nervous system lymphoma (PCNSL) will receive six cycles of the R-PMDT regimen. The R-PMDT regimen is administered as follows: rituximab (R, 375 mg/m²) is given as an intravenous infusion on day 0; methotrexate (M, 3.5 g/m²) is administered as a 3-hour intravenous infusion on day 1, with dose adjustment based on pre-treatment creatinine clearance; dexamethasone (D, 20 mg) is given intravenously on days 1-4; thiotepa (T, 30 mg/m²) is administered intravenously on day 1; and pirtobrutinib (P, 200 mg once daily) is taken orally on days 4-21. After completion of six cycles, depending on the investigator's decision, patients may receive consolidation or maintenance therapy, including but not limited to autologous hematopoietic stem cell transplantation, radiotherapy, or pirtobrutinib maintenance. The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluation of the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-PMDT | Experimental | Drug: R-PMDTEligible patients will receive six cycles of the R-PMDT regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- LVEF ≥55% by echocardiography
Key exclusion criteria (8 listed)
- 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.
- Hypersensitivity to any study drug or its components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-PMDTRituximab (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. | Drug | R-PMDT |
Primary outcome
Overall response rate (ORR)
Time frame: up to 2 years
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.
3 secondary outcomes
Complete response rate (CRR)
Time frame: up to 2 years
Progression-Free-Survival (PFS)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dehui Zou, Docter contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-PMDT in people with Primary Central Nervous System (CNS) Lymphoma, run by Zou Dehui at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Liu, Docter (86-022-23608461, liuwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.