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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05184842 | Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML | PHASE2 | RECRUITING | 91 | — | — | Mar 23, 2022 | Mar 1, 2027 | Jan 5, 2026 | 3 | United States |
The percentage of participants who are able to continue on treatment without dose interruptions or delays was defined as not having to delay or interrupt treatment due to toxicity or intolerability for more than two weeks during the 12-week induction period.
| Arm | Type | Description |
|---|---|---|
| Decitabine/Venetoclax (Single Arm) | EXPERIMENTAL | Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitaboine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). |
| Name | Type | Description |
|---|---|---|
| Venetoclax | DRUG | Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle) |
| Decitabine | DRUG | Decitabine 0.2 mg/kg subcutaneous (SQ) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24) |
Inclusion Criteria: * Patient must have a diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN) with a histopathologic diagnosis confirmed by hematopathology review * Indication for therapy with potential sensitivity to h...