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This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib | Experimental | Induction therapy: Patients receive Orelabrutinib at a dose of 25 mg once daily on days 1-28 and rituximab at a dose of 375mg/m2 on day 1. Treatment cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. If patients achieve CR or PR or SD, they will be treated with maintenance therapy Maintenance therapy: Patients receive Orelabrutinib every day at a dose of 150mg for up to two years in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib and Rituximab | Drug | Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response rate | Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | Complete remission rate will be determined on the basis of investigator | 2 years |
| Progression Free Survival | The time from the start of treatment to the progression of the tumor or death (due to any cause). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qingqing Cai | Sun Yat-Sen University Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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|
| Orelabrutinib | Drug | Orelabrutinib 150mg po qd |
|
| 4 years |
| Overall Survival | The time from the start of treatment to time of death (due to any cause). | 4 years |
| Duration of Response | The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause). | 4 years |
| Percentage of Participants With Adverse Events | Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0 | 4 years |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, | Not yet recruiting | Guangzhou | Guangdong | 51000 | China |
|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, | Recruiting | Guangzhou | Guangdong | 51000 | China |
|
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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