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Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL

ConditionDLBCL - Diffuse Large B Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This study aims to evaluate the efficacy of combining pirtobrutinib, lisaftoclax, and rituximab (PVR) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy and to explore a more effective treatment strategy for this patient population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old.

Capable of understanding and voluntarily signing written informed consent.

ECOG performance 0 ~ 3.

Anticipated survival ≥3 months

Disqualifiers

Prior treatment failure or resistance to pirtobrutinib or BCL2 inhibitors.

Prior Anticancer Therapy:Chemotherapy, radiotherapy, immunotherapy, or antibody-based anticancer therapy within the specified washout period.Traditional Chinese herbal medicine with antitumor indications.Small-molecule targeted therapy within 2 weeks before study treatment initiation. ADCs or cytotoxic therapy within 10 weeks before study treatment initiation.

Participation in another investigational drug study within 4 weeks prior to the first dose of study treatment.

Systemic corticosteroid therapy (>5 days within 14 days prior to treatment) at doses exceeding >10 mg/day dexamethasone (or equivalent) for CNS disease control.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pirtobrutinib

    Drug

    200mg qd po

  • Lisaftoclax

    Drug

    cycle 1: 200mg qd d1-7; 400mg qd d8-d28；Cycle 2: 400mg qd d1-d28 po

  • Rituximab

    Drug

    375mg/m2 d1 intravenous drip

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Pirtobrutinib, Lisaftoclax, and RituximabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

The rate of patients who achieved CR or PR after 2 cycles of PVR regimen

Time frame
At the end of 2 cycles of PVR regimen (each cycle is 28 days)

Secondary outcomes

1

Complete response rate(CRR)

The rate of patients who achieved CR after 2 cycles of PVR regimen

Time frame
At the end of 2 cycles of PVR regimen (each cycle is 28 days)
2

Adverse Events

The safety during induction treatment

Time frame
During induction treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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