Diffuse Large B-Cell Lymphoma
Conditions
Keywords
Orelabrutinib
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.
Interventions
DRUGOrelabrutinib
Orelabrutinib 150mg qd PO
BIOLOGICALRituximab
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle
DRUGCHOP-like Regimen
cyclophosphamide, anthracene nucleus chemotherapeutics（doxorubicin，liposomal doxorubicin, etc.）, vinca alkaloids（vincristine, vindesine, etc.），and glucocorticoid （dexamethasone，prednison, etc.）.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | At the end of Cycle 3 and Cycle 6（each cycle is 21 days） | The rate of patients who achieved CR or PR after treatment by OR-CHOP-like |
| Progression-free survival（PFS） | up to 24 month after the end of last patient's treatment | PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up |
| Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events | initiation of study drug until 30 days after last dose | The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events |
| Mini response rate | the first 21 days | The rate of patients who achieve ≥25% tumor reduction after OR treatment |
Countries
China
Contacts
Primary ContactZhengming Jin
Backup ContactChangju Qu
Outcome results
None listed