Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

NCT05498259 | Unknown Phase 2

• 1 other identifier: ORIENT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Orelabrutinib

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  The rate of patients who achieved complete response after treatment by OR-CHOP-like

  At the end of Cycle 6（each cycle is 21 days）

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  At the end of Cycle 3 and Cycle 6（each cycle is 21 days）

• Progression-free survival（PFS）

  up to 24 month after the end of last patient's treatment

• Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events

  initiation of study drug until 30 days after last dose

• Mini response rate

  the first 21 days

Study Arms (1)

Orelabrutinib+R-CHOP-like

EXPERIMENTAL

Orelabrutinib plus Rituximab for 21 days; Following Imaging examinations, patients with ≥25% tumor reduction, treat with orelabrutinib 150mg qd orally plus R-CHOP-like for 6 cycles; whereas, patients with \<25% tumor reduction, withdraw from the study，treat with R-CHOP-like alone for 6 cycle

Drug: Orelabrutinib; Biological: Rituximab; Drug: CHOP-like Regimen

Interventions

Orelabrutinib DRUG

Orelabrutinib 150mg qd PO

Orelabrutinib+R-CHOP-like

Rituximab BIOLOGICAL

Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle

Orelabrutinib+R-CHOP-like

CHOP-like Regimen DRUG

cyclophosphamide, anthracene nucleus chemotherapeutics（doxorubicin，liposomal doxorubicin, etc.）, vinca alkaloids（vincristine, vindesine, etc.），and glucocorticoid （dexamethasone，prednison, etc.）.

Orelabrutinib+R-CHOP-like

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed Non-GCB DLBCL
• Age ≥18 and ≤70 years
• At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm)
• ECOG performance status 0-2
• Lymphoma International Prognostic Score (IPI) ≥ 2
• Life expectancy ≥ 6 months
• Adequate organ and marrow function
• Agreement to practice birth control from the time of enrollment until the follow-up period of the study

You may not qualify if:

• Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis
• All patients with primary central nervous system lymphoma
• History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist
• Requires treatment with strong /moderate CYP3A inhibitors or inducers
• Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease
• HIV infection and/or active hepatitis B or active hepatitis C infection
• Uncontrolled active systemic infection
• Known hypersensitivity or contraindications to any drug involved in the study
• Pregnant or lactating women

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

orelabrutinib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Zhengming Jin

CONTACT

+86 0512 67781856; jinzhengming519519@163.com

Changju Qu

CONTACT

+86 0512 67781856; qcj310@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 12, 2022
• Study Start: July 27, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 3, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after the end of the study

Locations

CN (1)