A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Complete Response Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Orelabrutinib (Drug)
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
Intervention: Rituximab (Biological)
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
Intervention: CHOP-like Regimen (Drug)
Outcomes
Primary Outcomes
Complete Response Rate
Time Frame: At the end of Cycle 6（each cycle is 21 days）
The rate of patients who achieved complete response after treatment by OR-CHOP-like
Secondary Outcomes
- 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)