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This is a single arm, multi-center study to evaluate the efficacy and safety of orelabrutinib for Chronic lymphocytic lymphoma(CLL)/small lymphocytic lymphoma (SLL) patients who are slowly responding to Ibrutinib switched to Orelabrutinib.
The eligible CLL/SLL patients who are slowly responding to Ibrutinib will be switched to Orelabrutinib treatment. The patients will receive Orelabrutinib 150mg oral daily (28 days/cycle) for up to 2 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orelabrutinib | Experimental | CLL/SLL patients who are slowly responding to ibrutinib are switched to orelabrutinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orelabrutinib | Drug | Orelabrutinib 150mg po qd d1-28, up to 2 years or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first). |
| Measure | Description | Time Frame |
|---|---|---|
| ORR at cycle 3 after switched to orelabrutinib | Overall response rate is defined as the proportion of patients with a best response of CR/CRi and PR/PR-L | at cycle 3 (28 days/cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | The time from the first assessment of CR/CRi or PR/PR-L to progressive disease or death (due to any cause). | Up to 2 years |
| PFS | Progression-free survival is calculated from the date of start of therapy until the date of first documented progress or death due to any cause. |
| Measure | Description | Time Frame |
|---|---|---|
| BTK occupancy | The percentage of orelabrutinib/ibrutinib-bound BTK | Before taking orelabrutinib and take orelabrutinib for 3-6 cycles |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenmiao Yang | Contact | +8601088326666 | yangshenmiao@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shenmiao Yang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
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| Up to 2 years |
| OS | Overall survival is defined as the duration from start of treatment to time of death. | Up to 2 years |
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|