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The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.
The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rituximab(100mg), orelabrutinib(50mg), pomalidomide(4mg), miniCHOP-like | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab 375mg/m2 ivgtt d1; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate(ORR) after Pro-miniCHOP-like regimen | The rate of patients who achieved complete response and partial response after Pro-miniCHOP-like regimen. | At the end of cycle 6 (each cycle is 21 days) |
| Complete Response Rate(CRR) after Pro-miniCHOP-like regimen | The rate of patients who achieved complete response after Pro-miniCHOP-like regimen. | At the end of cycle 6 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 28 days after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengming Jin | Contact | 67781856 | jinzhengming519519@163.com | |
| Changju Qu | Contact | 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 |
|---|---|
| D000069283 | Rituximab |
| C000729508 | orelabrutinib |
| C467566 | pomalidomide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Orelabrutinib | Drug | Orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity; |
|
|
| Pomalidomide | Drug | Pomalidomide 4mg d1-7 each cycle. After Phase II of treatment, single agent pomalidomide 4 mg d1-d7 in 21-day cycles for 2 years. |
|
|
| Pro-miniCHOP-like regimen | Drug | rituximab 375mg/m2 ivgtt d1; orelabrutinib 150mg per day oral administration till progresses or intolerant toxicity; pomalidomide 4mg d1-7; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6. |
|
| R-miniCHOP-like regimen | Drug | rituximab 375mg/m2 ivgtt d1; cyclophosphamide 400mg/m2 ivgtt d2; doxorubicin 25mg/m2 ivgtt d2/ doxorubicin liposome 15 mg/m2 ivgtt d2; vindesine 2mg ivgtt d2; dexamethasone 10mg ivgtt d2-6. |
|
| Overall Response Rate(ORR) after Pro induction regimen | The rate of patients who achieved complete response and partial response after Pro induction regimen. | At the end of a cycle 1 of induction therapy period (each cycle is 21 days) |
| Complete Response Rate(CRR) after Pro induction regimen | The rate of patients who achieved complete response after Pro induction regimen. | At the end of a cycle 1 of induction therapy period (each cycle is 21 days) |
| Overall Survival (OS) | OS will be assessed from the first drug given to date of death or end of follow-up. | Up to 2 years after the end of last patient's treatment |
| Progression Free Survival (PFS) | PFS will be assessed from the first drug given to date of progression, relapse, death or end of follow-up. | Up to 2 years after the end of last patient's treatment |
| 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 |