Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Venetoclax combined with Ibrutinib · 1 trial · 1 indication
Rate of BM-uMRD is defined by negative MRD in the bone marrow by flow cytometry at a sensitivity of 10\^-4. The Clopper Pearson method is used to estimate the 95% two-sided confidence interval (CI) of the rate of BM-uMRD.
| Arm | Type | Description |
|---|---|---|
| CLL/SLL patients on ibrutinib monotherapy for ≥ 6 months | EXPERIMENTAL | - |
| CLL/SLL patients on zanubrutinib monotherapy for ≥ 6 months | EXPERIMENTAL | - |
| CLL/SLL patients on acalabrutinib monotherapy for ≥ 6 months | EXPERIMENTAL | - |
| CLL/SLL patients on orelabrutinib monotherapy for ≥ 6 months | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Venetoclax combined with Ibrutinib | DRUG | All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using ibrutinib. After the completion of combination therapy, patients will stop both the ibrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and ibrutinib will continue for an additional 12 cycles. Venetoclax and ibrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Ibrutinib is intended to be admistratered orally 420mg once daily. |
| Venetoclax combined with Zanubrutinib | DRUG | All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using zanubrutinib. After the completion of combination therapy, patients will stop both the zanubrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and zanubrutinib will continue for an additional 12 cycles. Venetoclax and zanubrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Zanubrutinib is intended to be admistratered orally 160mg twice daily. |
| Venetoclax combined with Acalabrutinib | DRUG | All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using acalabrutinib. After the completion of combination therapy, patients will stop both the acalabrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and acalabrutinib will continue for an additional 12 cycles. Venetoclax and acalabrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Acalabrutinib is intended to be admistratered orally 100mg twice daily. |
| Venetoclax combined with Orelabrutinib | DRUG | All Patients will be treated with venetoclax for 12 cycles after a standard 5-week dose ramp-up, as an add-on to the primary using orelabrutinib. After the completion of combination therapy, patients will stop both the orelabrutinib and venetoclax then be followed. Each cycle is 28 days. At the start of cycle 0, patients will start venetoclax by 20mg-50mg-100mg-200mg daily in a weekly dose escalation way. The combination of full dose venetoclax (400mg) and orelabrutinib will continue for an additional 12 cycles. Venetoclax and orelabrutinib will be continued until the completion of cycle 12, start of new CLL-directed therapies, disease progression or unacceptable toxicities, depending on which comes first. Orelabrutinib is intended to be admistratered orally 150mg once daily. |
Inclusion Criteria: * 1\. Age: 18-80 years-old. * 2\. Patients must have a diagnosis of CLL/SLL. * 3\. Detectable MRD by flow cytometry (10\^-4 sensitivity) in the peripheral blood. * 4\. Patients who are on BTK inhibitor monotherapy for more than 6 months. This study includes patients who are taki...