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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib | Drug | Orelabrutinib 150mg qd PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The rate of patients who achieved CR or PR after treatment by OR-CHOP-like | At the end of Cycle 3 and Cycle 6(each cycle is 21 days) |
| Progression-free survival(PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengming Jin | Contact | +86 0512 67781856 | jinzhengming519519@163.com | |
| Changju Qu | Contact | +86 0512 67781856 | qcj310@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
All the data would be available at the First Affiliated Hospital and other researchers after the end of the study
after the end of the study
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rituximab |
| Biological |
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle |
|
| CHOP-like Regimen | Drug | cyclophosphamide, anthracene nucleus chemotherapeutics(doxorubicin,liposomal doxorubicin, etc.), vinca alkaloids(vincristine, vindesine, etc.),and glucocorticoid (dexamethasone,prednison, etc.). |
|
PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up
| 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 | 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 | initiation of study drug until 30 days after last dose |
| Mini response rate | The rate of patients who achieve ≥25% tumor reduction after OR treatment | the first 21 days |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |