Active and planned clinical trials evaluating selinexor in myeloid malignancies
| Study population . | Interventions . | Phase . | Primary outcome(s) . | NCT no. . |
|---|---|---|---|---|
| JAKi-naïve MF | Selinexor plus ruxolitinib vs placebo plus ruxolitinib | 1/3 | Phase 1: MTD Phase 3: SVR35 | 04562389 |
| MF, R/R, or intolerant to JAKi | Selinexor monotherapy | 2 | Change in spleen volume | 03627403 |
| MF, JAKi-naïve with moderate thrombocytopenia (50 × 109/L-100 × 109/L) | Selinexor monotherapy | 2 | SVR35 | 05980806 |
| MF, R/R, or intolerant to JAKi | Selinexor monotherapy vs clinicians’ choice | 2 | SVR35 | 04562870 |
| AML, treatment-naïve | Selinexor plus induction/consolidation chemotherapy | 2 | OS | 02835222 |
| AML, treatment-naïve, not candidate for intensive chemotherapy | Selinexor plus azacitidine and venetoclax | 2 | CRc (CR/CRh/CRi) | 05736965 |
| AML, R/R DLBCL, R/R | Selinexor plus venetoclax | 1b | MTD and ORR | 03955783 |
| Pediatric and young adults (aged 2-30 y) with R/R AML | Selinexor and venetoclax plus salvage chemotherapy | 1 | MTD | 04898894 |
| Pediatric patients (aged 1-21 y) with R/R AML and ALL | Selinexor monotherapy | 1 | Safety and tolerability | 02091245 |
| Study population . | Interventions . | Phase . | Primary outcome(s) . | NCT no. . |
|---|---|---|---|---|
| JAKi-naïve MF | Selinexor plus ruxolitinib vs placebo plus ruxolitinib | 1/3 | Phase 1: MTD Phase 3: SVR35 | 04562389 |
| MF, R/R, or intolerant to JAKi | Selinexor monotherapy | 2 | Change in spleen volume | 03627403 |
| MF, JAKi-naïve with moderate thrombocytopenia (50 × 109/L-100 × 109/L) | Selinexor monotherapy | 2 | SVR35 | 05980806 |
| MF, R/R, or intolerant to JAKi | Selinexor monotherapy vs clinicians’ choice | 2 | SVR35 | 04562870 |
| AML, treatment-naïve | Selinexor plus induction/consolidation chemotherapy | 2 | OS | 02835222 |
| AML, treatment-naïve, not candidate for intensive chemotherapy | Selinexor plus azacitidine and venetoclax | 2 | CRc (CR/CRh/CRi) | 05736965 |
| AML, R/R DLBCL, R/R | Selinexor plus venetoclax | 1b | MTD and ORR | 03955783 |
| Pediatric and young adults (aged 2-30 y) with R/R AML | Selinexor and venetoclax plus salvage chemotherapy | 1 | MTD | 04898894 |
| Pediatric patients (aged 1-21 y) with R/R AML and ALL | Selinexor monotherapy | 1 | Safety and tolerability | 02091245 |
ALL, acute lymphoid leukemia; AML, acute myeloid leukemia; DLBCL, diffuse large B-cell lymphoma; CR, complete response; CRc, composite complete response; CRh, complete response with partial hematologic recovery; Cri, complete response with incomplete hematologic recovery; MTD, maximal tolerated dose; NCT, National Clinical Trial; ORR, overall response rate; R/R, relapsed and refractory.