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

NCT ID: NCT05498259

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-27
• Study Completion Date: 2025-01-01

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

Detailed Description

The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orelabrutinib+R-CHOP-like

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

Group Type: EXPERIMENTAL

Orelabrutinib

Intervention Type: DRUG

Orelabrutinib 150mg qd PO

Rituximab

Intervention Type: BIOLOGICAL

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

CHOP-like Regimen

Intervention Type: DRUG

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

Interventions

Orelabrutinib

Orelabrutinib 150mg qd PO

Intervention Type: DRUG

Rituximab

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

Intervention Type: BIOLOGICAL

CHOP-like Regimen

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed Non-GCB DLBCL

2. Age ≥18 and ≤70 years

3. At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm)

4. ECOG performance status 0-2

5. Lymphoma International Prognostic Score (IPI) ≥ 2

6. Life expectancy ≥ 6 months

7. Adequate organ and marrow function

8. Agreement to practice birth control from the time of enrollment until the follow-up period of the study

Exclusion Criteria

1. Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis

2. All patients with primary central nervous system lymphoma

3. History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist

4. Requires treatment with strong /moderate CYP3A inhibitors or inducers

5. 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

6. HIV infection and/or active hepatitis B or active hepatitis C infection

7. Uncontrolled active systemic infection

8. Known hypersensitivity or contraindications to any drug involved in the study

9. Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhengming Jin

Role: CONTACT

jinzhengming519519@163.com

+86 0512 67781856

Changju Qu

Role: CONTACT

qcj310@163.com

+86 0512 67781856

Facility Contacts

Zhengming Jin

Role: primary

Other Identifiers

ORIENT

Identifier Type: -

Identifier Source: org_study_id