Selected ongoing phase 2 clinical trials of frontline chemotherapy-free regimens
| Regimen . | Trial . | Cycles . |
|---|---|---|
| Venetoclax + ibrutinib49 | CAPTIVATE trial; 150 patients. Primary end point: ibrutinib use in uMRD with assessment of disease-free survival at 1 y (n = 11). 55% CR; 100% uMRD in PB. | 12, cont. ibrutinib based on MRD |
| Venetoclax + ibrutinib48 | 80 patients with high-risk features. Primary end point: CR/CRi. 92% CR/CRi at 12 mo. | 24 |
| Ibrutinib + venetoclax + obinutuzumab50 | 25 patients. Primary end point: MRD-negative CR at EOT. 52% CR/CRi; 58% uMRD. | 14 |
| Phase 3: Alliance 041702 for elderly patients, ECOG 9161 for young fit patients | ||
| Acalabrutinib + venetoclax + obinutuzumab52 | 72 patients. Primary end point: uMRD CR at EOT. 75% uMRD at EOT. | 15-24, based on MRD |
| Zanubrutinib + venetoclax + obinutuzumab52 | 77 patients. Primary end point: establish rate of uMRD CR (time frame: 1 y). 68% uMRD at 8 mo. | Up to 12, based on MRD |
| Regimen . | Trial . | Cycles . |
|---|---|---|
| Venetoclax + ibrutinib49 | CAPTIVATE trial; 150 patients. Primary end point: ibrutinib use in uMRD with assessment of disease-free survival at 1 y (n = 11). 55% CR; 100% uMRD in PB. | 12, cont. ibrutinib based on MRD |
| Venetoclax + ibrutinib48 | 80 patients with high-risk features. Primary end point: CR/CRi. 92% CR/CRi at 12 mo. | 24 |
| Ibrutinib + venetoclax + obinutuzumab50 | 25 patients. Primary end point: MRD-negative CR at EOT. 52% CR/CRi; 58% uMRD. | 14 |
| Phase 3: Alliance 041702 for elderly patients, ECOG 9161 for young fit patients | ||
| Acalabrutinib + venetoclax + obinutuzumab52 | 72 patients. Primary end point: uMRD CR at EOT. 75% uMRD at EOT. | 15-24, based on MRD |
| Zanubrutinib + venetoclax + obinutuzumab52 | 77 patients. Primary end point: establish rate of uMRD CR (time frame: 1 y). 68% uMRD at 8 mo. | Up to 12, based on MRD |
cont, continuous; EOT, end of therapy; PB, peripheral blood.