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Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma

25. juni 2026 opdateret af: Ou Bai, MD/PHD

Efficacy and Safety of Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma: a Single-center, Single-arm, Prospective Study

This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • The First Bethune Hospital of Jilin University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients of any gender, aged ≥18 years;
  • Pathologically, NGS, and imaging confirmed diagnosis of MCD subtype DLBCL (including IP-LBCLs);
  • No prior treatment history;
  • Serum creatinine ≤2 times the upper limit of normal or eGFR ≥40 ml/min;
  • Bilirubin <1.5 times the upper limit of normal;
  • Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

  • Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
  • Patients with a history of stroke or bleeding within the past 6 months;
  • Patients requiring treatment with strong CYP3A inhibitors;
  • Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection;
  • Patients with a history of organ transplantation;
  • Patients with a history of or concurrent other malignant tumors.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL

For MCD subtype DLBCL (including IP-LBCLs) that have undergone two cycles of induction therapy, combine orelabrutinib treatment starting from the third cycle.

For patients with poor prognostic factors (meeting one of the following: Ann Arbor stage III/IV; IPI score 3-5; aaIPI score 2-3; high-intermediate or high-risk group per MSKCC and/or IELSG criteria), continue with two additional cycles of orelabrutinib-combined induction therapy, followed by orelabrutinib monotherapy maintenance for 2 years or until disease progression or intolerable toxicity.

For patients without poor prognostic factors, administer orelabrutinib monotherapy maintenance for 1 year or until disease progression or intolerable toxicity.
Medicin: R-CHOP+Orelabrutinib
R-CHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Vincristine: 1.4 mg/m², Day 1 (maximum single dose: 2 mg) Prednisone: 100 mg, Days 1-5 Orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Andre navne:
  • Rituximab
  • Cyclofosfamid
  • Prednison
  • Doxorubicin
  • Vincristine
  • Orelabrutinib
Medicin: POLA-R-CHP+orelabrutinib
POLA-R-CHP+orelabrutinib Rituximab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Andre navne:
  • Rituximab
  • Cyclofosfamid
  • Prednison
  • Doxorubicin
  • orelabrutinib
  • Vepoliximab
Medicin: R-miniCHOP +orelabrutinib
R-miniCHOP Regimen Rituximab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Andre navne:
  • Rituximab
  • Cyclofosfamid
  • Prednison
  • Doxorubicin
  • Vincristine
  • orelabrutinib
Medicin: Zuberitamab-CHOP+orelabrutinib
Zuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Andre navne:
  • Cyclofosfamid
  • Prednison
  • Doxorubicin
  • Vincristine
  • Zuberitamab
Medicin: POLA-Hi-CHP+orelabrutinib
POLA-Hi-CHP+orelabrutinib Zuberitamab: 375 mg/m², Day 1 Vepoliximab: 1.8 mg/kg, Day 1 Cyclophosphamide: 750 mg/m², Day 1 Doxorubicin: 50 mg/m², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Andre navne:
  • Cyclofosfamid
  • Prednison
  • Doxorubicin
  • orelabrutinib
  • Vepoliximab
  • Zuberitamab
Medicin: Hi-miniCHOP +orelabrutinib
Hi-miniCHOP Regimen Zuberitamab: 375 mg/m², Day 0 Cyclophosphamide: 400 mg/m², Day 1 Doxorubicin: 25 mg/m², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg/m², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days/cycle during maintenance therapy
Andre navne:
  • Cyclofosfamid
  • Doxorubicin
  • Vincristine
  • orelabrutinib
  • Zuberitamab
  • Prednisone,
Medicin: RMTO
RMTO Regimen Rituximab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Andre navne:
  • Rituximab
  • Methotrexat
  • Thiotepa
  • orelabrutinib
Medicin: HiMTO
HiMTO Regimen Zuberitamab: 375 mg/m², Day 1 Methotrexate: 3.5 g/m², Day 2 Thiotepa 30 mg/m² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Andre navne:
  • Methotrexat
  • Thiotepa
  • orelabrutinib
  • Zuberitamab
Medicin: Pola-R-miniCHP+O
Pola-R-miniCHP Regimen Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Rituximab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Andre navne:
  • Rituximab
  • Cyclofosfamid
  • Prednison
  • Doxorubicin
  • Polatuzumab vedotin
Medicin: Pola-Hi-miniCHP
Pola-Hi-miniCHP Regimen (21-day cycle, up to 6 cycles) Polatuzumab vedotin: 1.8 mg/kg IV, Day 1 Zuberitamab: 375 mg/m² IV, Day 1 Cyclophosphamide: 400 mg/m² IV, Day 1 Doxorubicin: 25 mg/m² IV, Day 1 Prednisone: 40 mg/m² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days/cycle
Andre navne:
  • Cyclofosfamid
  • Prednison
  • Doxorubicin
  • orelabrutinib
  • Zuberitamab
  • Polatuzumab vedotin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
2year PFS
Tidsramme: From the start of treatment up to 2 years
The percentage of subjects who had not experienced disease progression or all-cause death at 24 months from first dose, relative to the total enrolled population.
From the start of treatment up to 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ORR
Tidsramme: From the start of treatment up to 2 years
The proportion of patients who achieved a PR or better response at the end of therapy
From the start of treatment up to 2 years
CRR
Tidsramme: From the start of treatment up to 2 years
Proportion of patients achieving CR at the end of treatment
From the start of treatment up to 2 years
OS
Tidsramme: From the start of treatment up to 2 years
Time from treatment initiation to death from any cause
From the start of treatment up to 2 years
AEs
Tidsramme: From the start of treatment up to 2 years
All adverse medical events that occurred after the initiation of treatment
From the start of treatment up to 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ou Bai, MD/PHD

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

16. juni 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2031

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25K405-001

Plan for individuelle deltagerdata (IPD)

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INGEN

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