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

ConditionDLBCL - Diffuse Large B Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOu Bai, MD/PHD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCLExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

2year PFS

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.

Time frame
From the start of treatment up to 2 years

Secondary outcomes

1

ORR

The proportion of patients who achieved a PR or better response at the end of therapy

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

CRR

Proportion of patients achieving CR at the end of treatment

Time frame
From the start of treatment up to 2 years
3

OS

Time from treatment initiation to death from any cause

Time frame
From the start of treatment up to 2 years
4

AEs

All adverse medical events that occurred after the initiation of treatment

Time frame
From the start of treatment up to 2 years

Other outcomes

Sponsors and contacts

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

Ou Bai, MD/PHD

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: