Pirtobrutinib+Pola-R-CHP for Newly Diagnosed Non-GCB DLBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChangzhou No.2 People's Hospital
About this trial
This is a single-arm, open-label, multicenter clinical study evaluating the efficacy and safety of pirtobrutinib combined with Pola-R-CHP in previously untreated Non-GCB DLBCL. PET/CT assessment will be performed after 3 cycles of combination therapy. Patients achieving CR/PR will continue treatment for another 3 cycles, while those with PD/SD will be discontinued from the study. Patients achieving CR/PR after 6 cycles of treatment will undergo follow-up with PET/CT or contrast-enhanced CT every 3 months during the first year and every 6 months thereafter, until disease progression, death, withdrawal of informed consent, or study completion, whichever occurs first.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed Non-GCB DLBCL (per 2016 WHO diagnostic criteria);
Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per 2014 Lugano criteria);
Age 18-65 years, with expected survival >3 months;
No prior anti-lymphoma treatment;
Disqualifiers
Central nervous system involvement;
History of hypersensitivity to the study drug, drugs of the same class, or excipients;
Concurrent malignancy requiring treatment or intervention;
Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy);
Trial design
Design model
Single group
Treatments tested in this trial
Pirtobrutinib+Pola-R-CHP
DrugPirtobrutinib 200 mg once daily Polatuzumab vedotin 1.8 mg/kg intravenously on Day 1 Rituximab 375 mg/m² on Day 1 Cyclophosphamide 750 mg/m² on Day 1 Doxorubicin 50 mg/m² on Day 1 Prednisone 100 mg on Days 1 to 5 Each cycle lasts 21 days. PET/CT evaluation is conducted after 3 treatment cycles. Subjects who attain CR or PR will receive an additional 3 cycles of therapy. Subjects with PD or SD will be withdrawn from the study. Subjects who do not achieve CR or PR upon completion of 6 cycles will be withdrawn from the study.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Pirtobrutinib+Pola-R-CHP for newly diagnosed non GCB DLBCLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year progression-free survival (PFS) rate
Time frame
2 yearsSecondary outcomes
1
Objective Response Rate (ORR) after 6 cycles of induction therapy
Time frame
week 18，at the end of 6 cycles of induction therapy(each cycle is 21 days)2
Complete Response Rate (CRR) after 6 cycles of induction therapy
Time frame
week 18, at the end of 6 cycles of induction therapy(each cycle is 21 days)3
Overall Survival(OS)
Time frame
up to 4 years4
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Time frame
up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov
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