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Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation

ConditionDiffuse Large B-Cell Lymphoma (DLBCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Soochow University

About this trial

To evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and older, up to 70 years.

Participants must be able to understand and willing to sign the written informed consent form.

Eastern Cooperative Oncology Group performance status 0 to 3.

Life expectancy ≥3 months (as determined by the investigator).

Disqualifiers

Patients who have previously received systemic anti-tumor therapy.

Patients with central nervous system involvement.

Patients who received systemic adrenal corticosteroids for more than 5 days within 14 days prior to study drug administration, or who require daily doses of >10 mg of dexamethasone or equivalent drugs to control central nervous system disease.

Active concurrent malignancy requiring active treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • POLA-R-CHP

    Drug

    Induction treatment period (6 cycles, 21 days/cycle): Polatuzumab vedotin: 1.8 mg/kg, intravenous drip, Day 1 of each cycle Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle CHP/CDP Regimen Cyclophosphamide: 750 mg/m² , intravenous drip, Day 2 of each cycle Doxorubicin: 50 mg/m² , intravenous drip, Day 2 of each cycle or Doxorubicin Hydrochloride Liposome: 25 mg/m² , intravenous drip, Day 2 of each cycle Prednisone: 100 mg, Days 2-6 of each cycle. Consolidation treatment period (2 cycles, 21 days/cycle): Rituximab: 375 mg/m2, intravenous drip, Day 1 of each cycle

  • Orelabrutinib

    Drug

    Induction treatment period (6 cycles, 21 days/cycle)+Consolidation treatment period (2 cycles, 21 days/cycle). Orelabrutinib: 150mg orally per day from Days 1 to 21 of cycles 2-6 (MCD/BN2)

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Pola-R-CHP + orelabrutinib or Pola-R-CHPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

2-year progression-free survival(PFS)

PFS will be assessed from the start of the treament to date of progression, relapse, death or end of follow-up.

Time frame
From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary outcomes

1

Complete response rate(CRR)

The rate of patients who achieved CR after 6 cycles

Time frame
At the end of 6 cycles (each cycle is 21 days)
2

2-year overall survival(OS)

OS will be assessed from the start the treatment to date of death or end of follow-up.

Time frame
From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years

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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