PirtobrutinibPhase 2NCT07812493
Pirtobrutinib Plus Methotrexate-Based Chemoimmunotherapy for Systemic DLBCL With CNS Involvement
A Phase 2 study testing pirtobrutinib+MTX+immunolchemotherapy in people with Pirtobrutinib and Immunochemotherapy, run by Pengpeng Xu at 1 site in China.
Trial summary
This is an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with routinely-used clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Pirtobrutinib, Immunochemotherapy, DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- pirtobrutinib+MTX+immunolchemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must satisfy all of the following conditions to be enrolled in this study:
- 1.Fully understand the study and voluntarily provide written informed consent. 2.Age: 14-80 years old. 3.Estimated survival of more than 3 months as judged by the investigator. 4.Histologically or cytologically / flow-cytometry confirmed B-cell-derived diffuse large B-cell lymphoma (DLBCL).
- 5.Central nervous system (CNS) involvement: diagnosis is established if any one of the following is present: symptoms related to CNS involvement, abnormal imaging findings, or pathological evidence (positive cerebrospinal fluid (CSF) cytology, positive biopsy of brain parenchymal lesions, or positive CSF-ctDNA).
- 6.Non-hematologic toxicities related to prior therapy shall have recovered to Grade 1 or baseline (per NCI-CTCAE Version 5.0), alopecia excluded.
- 7.Bone marrow and organ function meet the following criteria (no blood transfusion, G-CSF administration, or pharmacologic correction within 14 days prior to screening):
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; hemoglobin ≥ 60 g/L.
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- Liver function: serum total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN in the presence of liver involvement); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN in the presence of liver involvement).
- Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- Renal function: serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 30 mL/min.
- Calculationformula(Cockcroft-Gault):Male:Cr(mL/min) = (140 - age) × bodyweight (kg) / (72 × serum creatinine(mg/dL))Female:Cr(mL/min) = (140 - age) × body weight (kg) × 0.85 / (72 × serum creatinine (mg/dL)) 8.Women of child-bearing potential and men with reproductive potential have no plan for conception with their partners during the study and for 3 months after treatment discontinuation. They must adopt one of the following effective contraceptive measures throughout the study period and for 3 months after treatment discontinuation: abstinence, physical contraception (e.g., sterilization, condoms), or hormonal contraceptives initiated at least 3 months prior to the first study drug administration. Male subjects shall refrain from sperm donation from treatment initiation through 3 months after treatment discontinuation. The patient or legal guardian voluntarily signs the informed consent form.
- 9.Good compliance and willingness to adhere to visit schedules, drug administration plans, laboratory tests, and other study procedures.
Who cannot join
- Patients meeting any one of the following criteria will be excluded from this study:
- Contraindication to any drug in the treatment regimen.
- History of active liver disease, including viral or other hepatitis, or liver cirrhosis. (Active hepatitis B is defined as HBV-DNA above the upper limit of normal; active hepatitis C is defined as positive HCV antibody. Subjects with positive HCV antibody but negative HCV-RNA are eligible for enrollment.)
- Human immunodeficiency virus (HIV) infection.
- Congestive heart failure (New York Heart Association [NYHA] functional class > 2); medical history of acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack within the preceding six months.
- Congenital long-QT syndrome, or QTc > 480 ms. (Note: QTc interval shall be calculated by the Fridericia's formula: QTcF = QT/(RR)^0.33.)
- Pregnant or breastfeeding women, or subjects planning to become pregnant during the study period.
- Documented prior history of neurological or psychiatric disorders; or history of psychotropic substance abuse or illicit drug use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
zhizhou Xia, PhD, +86 13671898350, dr_wangli@126.com
About this study
Official title: Efficacy and Safety of Methotrexate (MTX) Combined With Chemoimmunotherapy Plus Pirtobrutinib in Patients With Systemic Diffuse Large B-Cell Lymphoma (DLBCL) and Central Nervous System Involvement
This is an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with routinely-used clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement.
Read the detailed description
This was an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with conventional clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement. Subjects meeting the inclusion/exclusion criteria were enrolled into the experimental arm after providing written informed consent. Each treatment cycle lasted 3 weeks. Following 6 cycles of induction therapy, subjects who failed to achieve partial response (PR) or experienced disease progression at any time point were withdrawn from the study and received salvage therapy. Subjects achieving complete response (CR) or PR proceeded to autologous stem-cell transplantation if they were young and eligible for transplantation. For patients with stable disease (SD) or progressive disease (PD), subsequent treatment was administered at the investigator's discretion, followed by follow-up observation for up to 3 years.
- Conditions
- Pirtobrutinib, Immunochemotherapy, DLBCL - Diffuse Large B Cell Lymphoma, CNS Involvement of Systemic Lymphoma
- Being tested
- pirtobrutinib+MTX+immunolchemotherapy
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pirtobrutinib+MTX+immunolchemotherapyDrug
Induction therapy: Pirtobrutinib 200 mg once daily, combined with MTX (thiotepa for patients intolerant to MTX) plus chemoimmunotherapy regimens.
MTX 3.5 g/m² or thiotepa 30 mg/m²; R-CHOP regimen:
Rituximab 375 mg/m² Day 0 Cyclophosphamide 750 mg/m² Day 1 Doxorubicin 50 mg/m² Day 1 Vincristine 1.4 mg/m² Day 1 Prednisone 100 mg/day Days 1-5
MTX 3.5 g/m² or thiotepa 30 mg/m²; Pola-R-CHP regimen:
Rituximab 375 mg/m² Day 1 Cyclophosphamide 750 mg/m² Day 1 Doxorubicin 50 mg/m² Day 1 Prednisone 100 mg/day Days 1-5 Polatuzumab vedotin 1.8 mg/kg Day 1 Each cycle was 21 days, for a total of 6 cycles.
Consolidation therapy: After achieving CR or PR, young and transplant-eligible subjects could receive autologous stem-cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| pirtobrutinib+MTX+immunochemotherapy | Experimental | Not described Receives: Drug: pirtobrutinib+MTX+immunolchemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRR(complete remission rate) after 6 cycles of induction therapy
Measured: Week 18，at the end of induction therapy(each cycle is 21 days)
Secondary outcomes (3)
2-year PFS rate
Measured: 2 years
overall survival (OS)
Measured: From first study treatment until death from any cause, up to 4 years
objective response rate (ORR)
Measured: week 18，at the end of 6 cycles of induction therapy(each cycle is 21 days )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PirtobrutinibStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pengpeng Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pengpeng Xu, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812493
- Sponsor's protocol ID
- 2026-691
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Methotrexate (MTX) Combined With Chemoimmunotherapy Plus Pirtobrutinib in Patients With Systemic Diffuse Large B-Cell Lymphoma (DLBCL) and Central Nervous System Involvement
- ClinicalTrials.gov ID
- NCT07812493
- Acronym / sponsor ID
- 2026-691
- Conditions
- Pirtobrutinib, Immunochemotherapy, DLBCL - Diffuse Large B Cell Lymphoma, CNS Involvement of Systemic Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Pengpeng XuUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 10 Sep 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.
This is an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with routinely-used clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement.
Detailed description
This was an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with conventional clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement. Subjects meeting the inclusion/exclusion criteria were enrolled into the experimental arm after providing written informed consent. Each treatment cycle lasted 3 weeks. Following 6 cycles of induction therapy, subjects who failed to achieve partial response (PR) or experienced disease progression at any time point were withdrawn from the study and received salvage therapy. Subjects achieving complete response (CR) or PR proceeded to autologous stem-cell transplantation if they were young and eligible for transplantation. For patients with stable disease (SD) or progressive disease (PD), subsequent treatment was administered at the investigator's discretion, followed by follow-up observation for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pirtobrutinib+MTX+immunochemotherapy | Experimental | Drug: pirtobrutinib+MTX+immunolchemotherapy |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 1.Fully understand the study and voluntarily provide written informed consent. 2.Age: 14-80 years old. 3.Estimated survival of more than 3 months as judged by the investigator. 4.Histologically or cytologically / flow-cytometry confirmed B-cell-derived diffuse large B-cell lymphoma (DLBCL).
- 5.Central nervous system (CNS) involvement: diagnosis is established if any one of the following is present: symptoms related to CNS involvement, abnormal imaging findings, or pathological evidence (positive cerebrospinal fluid (CSF) cytology, positive biopsy of brain parenchymal lesions, or positive CSF-ctDNA).
- 6.Non-hematologic toxicities related to prior therapy shall have recovered to Grade 1 or baseline (per NCI-CTCAE Version 5.0), alopecia excluded.
- 7.Bone marrow and organ function meet the following criteria (no blood transfusion, G-CSF administration, or pharmacologic correction within 14 days prior to screening):
- Bone marrow function: absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; hemoglobin ≥ 60 g/L.
Key exclusion criteria (8 listed)
- Contraindication to any drug in the treatment regimen.
- History of active liver disease, including viral or other hepatitis, or liver cirrhosis. (Active hepatitis B is defined as HBV-DNA above the upper limit of normal; active hepatitis C is defined as positive HCV antibody. Subjects with positive HCV antibody but negative HCV-RNA are eligible for enrollment.)
- Human immunodeficiency virus (HIV) infection.
- Congestive heart failure (New York Heart Association [NYHA] functional class > 2); medical history of acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack within the preceding six months.
- Congenital long-QT syndrome, or QTc > 480 ms. (Note: QTc interval shall be calculated by the Fridericia's formula: QTcF = QT/(RR)^0.33.)
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 |
|---|---|---|
| pirtobrutinib+MTX+immunolchemotherapyInduction therapy: Pirtobrutinib 200 mg once daily, combined with MTX (thiotepa for patients intolerant to MTX) plus chemoimmunotherapy regimens. MTX 3.5 g/m² or thiotepa 30 mg/m²; R-CHOP regimen: Rituximab 375 mg/m² Day 0 Cyclophosphamide 750 mg/m² Day 1 Doxorubicin 50 mg/m² Day 1 Vincristine 1.4 mg/m² Day 1 Prednisone 100 mg/day Days 1-5 MTX 3.5 g/m² or thiotepa 30 mg/m²; Pola-R-CHP regimen: Rituximab 375 mg/m² Day 1 Cyclophosphamide 750 mg/m² Day 1 Doxorubicin 50 mg/m² Day 1 Prednisone 100 mg/day Days 1-5 Polatuzumab vedotin 1.8 mg/kg Day 1 Each cycle was 21 days, for a total of 6 cycles. Consolidation therapy: After achieving CR or PR, young and transplant-eligible subjects could receive autologous stem-cell transplantation. | Drug | pirtobrutinib+MTX+immunochemotherapy |
Primary outcome
CRR(complete remission rate) after 6 cycles of induction therapy
Time frame: Week 18，at the end of induction therapy(each cycle is 21 days)
3 secondary outcomes
2-year PFS rate
Time frame: 2 years
overall survival (OS)
Time frame: From first study treatment until death from any cause, up to 4 years
objective response rate (ORR)
Time frame: week 18，at the end of 6 cycles of induction therapy(each cycle is 21 days )
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 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pirtobrutinib
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingEarly Phase 1
Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
RecruitingPhase 2
Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Chronic Lymphocytic Leukemia, Richter's Transformation
RecruitingPhase 3
Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial
Richter Syndrome, Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
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.
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 pirtobrutinib+MTX+immunolchemotherapy in people with Pirtobrutinib and Immunochemotherapy, run by Pengpeng Xu 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 11 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: opening soon, as of the sponsor's last update on 11 Sep 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 Li Wang, PhD (+86 13671898350, dr_wangli@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRR(complete remission rate) after 6 cycles of induction therapy (time frame: Week 18，at the end of induction therapy(each cycle is 21 days)). 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 11 Sep 2026.