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NCT Number: NCT07677813

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

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.

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location contact

ou bai, MD/PHD

CONTACT

[email protected]

13039046656

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

R-CHOP+Orelabrutinib

Drug

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

Other names: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Orelabrutinib

POLA-R-CHP+orelabrutinib

Drug

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

Other names: Rituximab, Vepoliximab, Cyclophosphamide, Doxorubicin, Prednisone, orelabrutinib

R-miniCHOP +orelabrutinib

Drug

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

Other names: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, orelabrutinib

Zuberitamab-CHOP+orelabrutinib

Drug

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

Other names: Zuberitamab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

POLA-Hi-CHP+orelabrutinib

Drug

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

Other names: Vepoliximab, Cyclophosphamide, Doxorubicin, Prednisone, orelabrutinib, Zuberitamab

Hi-miniCHOP +orelabrutinib

Drug

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

Other names: Zuberitamab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone,, orelabrutinib

RMTO

Drug

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

Other names: Rituximab, orelabrutinib, Thiotepa, Methotrexate

HiMTO

Drug

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

Other names: Zuberitamab, orelabrutinib, Thiotepa, Methotrexate

Pola-R-miniCHP+O

Drug

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

Other names: Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone

Pola-Hi-miniCHP

Drug

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

Other names: Polatuzumab vedotin, Cyclophosphamide, Doxorubicin, Prednisone, Zuberitamab, orelabrutinib

Primary outcomes

  1. 2year PFS

    Time frame: 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.

Secondary outcomes

  1. ORR

    Time frame: 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

  2. CRR

    Time frame: From the start of treatment up to 2 years

    Proportion of patients achieving CR at the end of treatment

  3. OS

    Time frame: From the start of treatment up to 2 years

    Time from treatment initiation to death from any cause

  4. AEs

    Time frame: From the start of treatment up to 2 years

    All adverse medical events that occurred after the initiation of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

ou bai, MD/PHD

CONTACT

[email protected]

13039046656

Sponsors and collaborators

Lead sponsor

Ou Bai, MD/PHD

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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