Health Trials

Pirtobrutinib Plus Methotrexate-Based Chemoimmunotherapy for Systemic DLBCL With CNS Involvement

ConditionsPirtobrutinibImmunochemotherapyDLBCL - Diffuse Large B Cell LymphomaCNS Involvement of Systemic Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-80
SponsorPengpeng Xu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Bone marrow function: absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; hemoglobin ≥ 60 g/L.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • pirtobrutinib+MTX+immunolchemotherapy

    Drug

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: pirtobrutinib+MTX+immunochemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

2-year PFS rate

Time frame
2 years
2

overall survival (OS)

Time frame
From first study treatment until death from any cause, up to 4 years
3

objective response rate (ORR)

Time frame
week 18，at the end of 6 cycles of induction therapy(each cycle is 21 days )

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pengpeng Xu

Lead sponsor

Ruijin Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: