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Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma

NCT05097443 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-11-19

No results posted yet for this study

Summary

B-cell non-Hodgkin's lymphoma (B-NHL) is the most common type of NHL. Although novel immunotherapies represented by anti-CD20 monoclonal antibodies and CAR-T cell therapies have significantly improved the prognosis of B-NHL patients, there are still nearly one-third of patients who are resistant to initial treatment or relapse after remission. R-CHOP combined with novel drugs was expected to improve the prognosis. Therefore, this study aimed to investigate the potential of Orelabrutinib combined with Rituximab and chemotherapy.

Conditions

  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Diffuse Large B-cell Lymphoma
  • Mantle Cell Lymphoma
  • B-cell NonHodgkin Lymphoma

Interventions

DRUG

Orelabrutinib+R-CHOP; Orelabrutinib+R-DA-EPOCH; Orelabrutinib+R-HD MTX;Orelabrutinib+R+other chemotherapies

Orelabrutinib+R-CHOP： Orelabrutinib 150mg qd; R-CHOP：Rituximab 375mg/m2 d0, Cyclophosphamide 750mg /m2 d1, Doxorubicin 50mg /m2 or Doxorubicin liposome 30-40 mg /m2 d1, Vincristine 1.4mg /m2 or Vindesine 3mg /m2 d1, Prednisone 100mg d1-5. Orelabrutinib+R-DA-EPOCH： Orelabrutinib 150mg qd； R-DA-EPOCH：Rituximab 375mg/m2 d0, Etoposide 50mg/ m2, Epirubicin 15mg/ m2, Vincristine 0.4mg/ m2, d1-4, Cyclophosphamide 750mg/ m2 d5, Prednisone 60mg/ m2 d1-5. Orelabrutinib+R-HD-MTX: Orelabrutinib 150mg qd; R-HD-MTX: Rituximab 375mg/m2 d0, Methotrexate 3.5g/ｍ2 d1. Orelabrutinib+ R+other regimens: Orelabrutinib 150mg qd； R+other regimens: Rituximab 375mg/m2 d0. The dose of other drugs depends on the regimen. All regimens follow every 21 days is one cycle, which can be extended to 28 days per cycle according to patients' specific tolerance. Dose adjustments of Orelabrutinib are allowed. The initial dose is 150 mg, QD, while the first adjustment is 100 mg, QD and the second adjustment is 50 mg, QD.

Sponsors & Collaborators

  • Shandong Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Xin Wang, PhD · Shandong Provincial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097443 on ClinicalTrials.gov