AzTrials
AzTrials

Relapsed and Refractory DLBCLPhase 2NCT07122609

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

A Phase 2 study testing Pirtobrutinib, R-GemOx and Polatuzumab Vedotin in people with Relapsed and Refractory DLBCL, run by Ruijin Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed and Refractory DLBCL
What is being tested?
Pirtobrutinib, R-GemOx and Polatuzumab Vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
5 Aug 2025to 15 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weili Zhao, Professor contact

86 02164370045

zwl_trial@163.com

China1 site

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Weili Zhao, Professor, 021-64370045, zhaoweili_sih@163.com

Other trials in China

About this study

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)

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.

Being tested
Pirtobrutinib, R-GemOx, Polatuzumab Vedotin
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirtobrutinibDrug

    Also called LOXO-305

    Dose:200mg，d1-21

  • R-GemOxDrug

    Dose: Rituximab: 375mg/m2, d1; Gemcitabine: 1000mg/m2, d2; Oxaliplatin:100mg/m2, d2

  • Polatuzumab VedotinDrug

    Dose: 1.8mg/kg，iv，d1 (For patient who is CD79b positive and has not previously received polatuzumab Vedotin)

Study groups in NCT07122609
Study groupRoleWhat they receive
pirtobrutinib+R-GemOx with or without polatuzumab vedotinExperimentalDLBCL patients will receive Pirto-R-GemOx for a total of 6 treatment cycles (21days per cycle). Patient who is CD79b positive and has not previously received polatuzumab Vedotin will combine with polatuzumab Vedotin.The efficacy will be evaluated every 3 cycles, young patients with CR will receive ASCT, CR patients who do not undergo ASCT or PR patients will continued for 3 cycles.If the efficacy is evaluated as CR or PR after 6 cycles, then ASCT for young patients, and lenalidomide maintenance treatment for elderly patients for 2 years (25mg, day 1-21, Q4W). ctDNA testing will be performed at baseline、before the second course、and at the end of treatment.
Receives: Drug: Pirtobrutinib; Drug: R-GemOx; Drug: Polatuzumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complete response rate(CRR)

    CRR after treated by pirto-R-GemOx±pola

    Measured: Up to 6 cycles (each cycle is 21 days)

Secondary outcomes (4)

  1. Objective response rate(ORR)

    ORR after treated by pirto-R-GemOx

    Measured: Up to 6 cycles (each cycle is 21 days) ± pola

  2. Progression-free survival (PFS)

    PFS after treated by pirto-R-GemOx±pola

    Measured: Up to 6 cycles (each cycle is 21 days)

  3. Overall Survival (OS)

    OS after treated by pirto-R-GemOx±pola

    Measured: up to 6 cycles(each cycle is 21 days)

  4. undetectable MRD rate

    undetectable MRD rate after treated by pirto-R-GemOx

    Measured: Up to 6 cycles (each cycle is 21 days) ± pola

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start5 Aug 2025 (estimated)
  3. Primary completion15 Aug 2026 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07122609
Sponsor's protocol ID
pirto-R-Gemox
Status last verified
Aug 2025
First submitted
27 Jul 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirtobrutinib, R-GemOx and Polatuzumab Vedotin in people with Relapsed and Refractory DLBCL, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weili Zhao, Professor (86 02164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response rate(CRR) (time frame: Up to 6 cycles (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07122609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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