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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07075016 | Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy | PHASE3 | RECRUITING | 227 | — | — | Aug 5, 2025 | Mar 1, 2029 | Aug 19, 2025 | 119 | Austria, Belgium +14 |
Event-free survival (EFS) in patients with newly diagnosed IDH1-mutated AML ineligible for intensive chemotherapy, measured from the date of randomization to the date of treatment failure, hematologic relapse from CR/CRh or death from any cause, whichever occurs first. Treatment failure is defined as lack of obtaining either CR or CRh by week 24. Patients evaluable for response but not achieving CR or CRh by week 24 will be considered a treatment failure at day 1 post randomization to avoid ambiguities of variable or prolonged periods without response. Patients who die before week 24 without response assessments will also be considered treatment failures at day 1 post randomization. Patients who are alive but not evaluable for response will be censored at day 1 post randomization. Patients who achieved CR or CRh by week 24 and are not known to have morphologic relapse or died will be censored at the date of the last clinical assessment.
| Arm | Type | Description |
|---|---|---|
| Placebo comparator: Venetoclax-placebo | PLACEBO_COMPARATOR | day 1-28 Placebo Treatment will be on a continuous 28-day cycle schedule continued until disease relapse, disease progression, development of unacceptable toxicity, death, withdrawal of subject or other protocol defined criteria for discontinuation (which ever comes first) |
| Experimental: Venetoclax | EXPERIMENTAL | day 1-28 Venetoclax Treatment will be on a continuous 28-day cycle schedule continued until disease relapse, disease progression, development of unacceptable toxicity, death, withdrawal of subject or other protocol defined criteria for discontinuation (which ever comes first) |
| Name | Type | Description |
|---|---|---|
| Venetoclax 400 | DRUG | day 1-28 per cycle |
| Placebo | DRUG | day 1-28 per cycle |
Inclusion Criteria: 1. Patient with newly diagnosed IDH1-mutated AML, or IDH1-mutated MDS/AML according to the 2022 International Consensus Classification (Appendix A). Patients with AML with both IDH1 and IDH2 mutation are eligible as well. Of note: in case both NPM1 and IDH1 are mutated and both ...