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
Qualifiers
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
Treatments tested in this trial
- Pirtobrutinib+Pola-R-CHP
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov