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Not yet recruiting NCT07122609

Pirtobrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin With or Without Polatuzumab Vedotin in Covalent BTK Inhibitor-Pretreated Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase II Interventional Relapsed and Refractory DLBCL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pirtobrutinib, R-GemOx, Polatuzumab Vedotin.
Who it may be relevant to
Registry conditions: Relapsed and Refractory DLBCL. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Study of Pirtobrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin With or Without Polatuzumab Vedotin (Pirto-R-GemOx±Pola) in Covalent BTK Inhibitor-Pretreated Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Overview

This is a prospective, single arm trial in patients with ≥ 18 years with relapsed and refractory DLBCL. Aim of this study is to evaluate the efficacy and safety of pirtobrutinib in combination with rituximab, gemcitabine, and oxaliplatin with or without polatuzumab vedotin (Pirto-R-GemOx±pola) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) previously treated with covalent BTK inhibitors.

Interventions

  • Drug Pirtobrutinib
    Dose:200mg，d1-21
  • Drug R-GemOx
    Dose: Rituximab: 375mg/m2, d1; Gemcitabine: 1000mg/m2, d2; Oxaliplatin:100mg/m2, d2
  • Drug Polatuzumab Vedotin
    Dose: 1.8mg/kg，iv，d1 (For patient who is CD79b positive and has not previously received polatuzumab Vedotin)

Primary outcome measures

  • complete response rate(CRR) [Time frame: Up to 6 cycles (each cycle is 21 days)]
Secondary outcome measures (4)
  • Objective response rate(ORR) [Time frame: Up to 6 cycles (each cycle is 21 days) ± pola]
  • Progression-free survival (PFS) [Time frame: Up to 6 cycles (each cycle is 21 days)]
  • Overall Survival (OS) [Time frame: up to 6 cycles(each cycle is 21 days)]
  • undetectable MRD rate [Time frame: Up to 6 cycles (each cycle is 21 days) ± pola]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed DLBCL (2016 WHO criteria) of MCD, BN2, N1 subtypes, double-expressor, intravascular large B-cell lymphoma, or other BTK-sensitive subtypes
  • Disease progression/relapse after covalent BTK inhibitor therapy
  • ≥1 measurable lesion (nodal >15mm/extranodal >10mm) on PET/CT within 28 days
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • age ≥18 years
  • Adequate organ function:

ANC ≥0.5×10⁹/L ；Platelets ≥50×10⁹/L (transfusion-independent)；Bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN；Cr ≤1.5×ULN or CrCl ≥30mL/min；LVEF ≥50% (NYHA class <III)

  • Life expectancy >3 months
  • Sign the written ICF, and be able to comply with the visits and related procedures stipulated in the protocol;
  • Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last treatment.

Exclusion criteria

  • DLBCL with central nervous system (CNS) or meningeal involvement
  • Histologically transformed DLBCL
  • Contraindications or hypersensitivity to any drug in the combination regimen
  • Major surgery within 4 weeks prior to treatment (excluding vascular access placement or biopsy)
  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's judgment, may compromise patient safety or compliance with study procedures
  • Poorly controlled cardiac clinical symptoms or diseases, including:

i. NYHA Class II or higher heart failure ii. Unstable angina iii. Myocardial infarction within 1 year iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment/intervention

  • Active hemorrhage
  • Poorly controlled systemic bacterial, viral, fungal, or parasitic infections (excluding fungal nail infections), or other clinically significant active diseases that render patients unsuitable for trial participation per investigator assessment
  • Patients with:Active chronic hepatitis B or C.Positive HBsAg and/or HBcAb or HCV antibodies at screening must demonstrate HBV DNA ≤2,500 copies/mL (or 500 IU/mL) to exclude active HBV/HCV infection requiring treatment.HBsAg/HBcAb-positive patients must receive antiviral prophylaxis.

HIV-infected patients and/or AIDS patients

  • Inability to swallow tablets, malabsorption syndrome, or any gastrointestinal disorder/ dysfunction that may impair drug absorption
  • Lactating or pregnant women
  • Psychiatric disorders or inability to provide informed consent
  • Any other condition deemed unsuitable for study participation by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07122609 · pirto-R-Gemox

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗