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

Soochow University

Status and phase: Enrolling; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05498259

ORIENT

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Orelabrutinib+R-CHOP-like

Experimental group

Description:

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

Treatment:

Drug: CHOP-like Regimen

Drug: Orelabrutinib

Biological: Rituximab