Pirtobrutinib + R-CHOP for Untreated Non-GCB DLBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChangzhou No.2 People's Hospital
About this trial
To evaluate the efficacy and safety of pirtobrutinib combined with R-CHOP in patients with newly diagnosed non-GCB diffuse large B-cell lymphoma (DLBCL)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histopathologically confirmed non-GCB diffuse large B-cell lymphoma (DLBCL) (per the 2016 WHO diagnostic criteria);
Whole-body PET/CT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per the 2014 Lugano Criteria);
Age 18-80 years, with estimated survival > 3 months;
No prior anti-lymphoma treatment;
Disqualifiers
Central nervous system involvement;
History of hypersensitivity to the study drug, similar agents, or excipients;
Concurrent other malignancies requiring treatment or intervention;
Major surgical procedure performed within 4 weeks prior to treatment (excluding vascular access catheterization or biopsy);
Trial design
Design model
Single group
Treatments tested in this trial
Pirtobrutinib plus R-CHOP
DrugThe treatment regimen consists of pirtobrutinib 200 mg orally on days 1-21 of each 21-day cycle for 6 cycles, combined with R-CHOP given as follows: rituximab 375 mg/m² intravenously on day 1; cyclophosphamide 750 mg/m² intravenously on day 2; doxorubicin 50 mg/m² intravenously on day 2; vincristine 1.4 mg/m² (maximum 2 mg) intravenously on day 2 for 6 cycles; and prednisone 100 mg orally on days 1-5 of each 21-day cycle for 6 cycles.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Pirtobrutinib+R-CHOP for newly diagnosed non GCB DLBCLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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）Secondary outcomes
1
Objective Response Rate (ORR) after 6 cycles of induction therapy
Time frame
week 18，at the end of induction therapy(each cycle is 21 days)2
Overall Survival (OS)
Time frame
up to 3 years3
Progression-Free Survival(PFS)
Time frame
up to 3 years4
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Time frame
up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov
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