Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03931291 | APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant | PHASE2 | COMPLETED | 33 | — | — | Sep 16, 2019 | Jan 14, 2022 | Mar 17, 2025 | 7 | United States |
Relapse-free survival (RFS) at 12 months or longer if data permits. RFS was defined as the time from HCT to relapse after HCT or death, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Experimental arm: APR-246 + azacitidine | EXPERIMENTAL | APR-246 and azacitidine maintenance therapy will continue for a maximum of 12 cycles |
| Name | Type | Description |
|---|---|---|
| APR-246 | DRUG | APR-246 will be administered on Days 1-4, with azacitidine on Days 1-5, of every 28 day cycle. Patients may receive a maximum of 12 cycles. |
Inclusion Criteria: 1. Patient must have previously met pre-transplantation eligibility. 2. Patient has received an allogeneic transplant for AML or MDS. 3. Any standard (non-study) conditioning \[MAC (myeloablative conditioning), RIC (reduced intensity conditioning), or NMA (non-myeloablative cond...