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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06034470 | Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms | PHASE1 | ACTIVE NOT_RECRUITING | 30 | — | — | Dec 18, 2023 | May 31, 2029 | May 7, 2026 | 1 | United States |
Dose-limiting toxicities (DLTs) for trial monitoring are defined as follows: a) Any Grade ≥4 organ toxicity; and b) prolonged severe myelosuppression, as defined by ANC \<500/µL and platelet count \<25,000/µL, for \>42 days after initiation (day 1) of FLAG-Ida chemotherapy in the absence of residual disease (assessed by European LeukemiaNet \[ELN\] response criteria).
| Arm | Type | Description |
|---|---|---|
| Treatment (PVEK, FLAG-Ida) | EXPERIMENTAL | See Detailed Description. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspirate |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Cytarabine | DRUG | Given IV |
| Echocardiography | PROCEDURE | Undergo ECHO |
| Fludarabine | DRUG | Given IV |
| Granulocyte Colony-Stimulating Factor | DRUG | Given SC |
| Idarubicin | DRUG | Given IV |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA scan |
| Pivekimab Sunirine | DRUG | Given IV |
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of untreated AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 5th edition of the World Health Organization (WHO) classification of hematolymphoid tumors. Patients with myelodysplastic, myeloprolife...