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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05199051 | A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML | PHASE2 | ACTIVE NOT_RECRUITING | 19 | — | — | Jun 3, 2023 | Jul 10, 2028 | Jan 5, 2026 | 12 | France |
The primary objective of the first stage is to evaluate the safety of combining gilteritinib with the Gemtuzumab Ozogamicin (GO) -cytarabine AGORA platform in patients with FLT3-ITD and/or FLT3-TKD mutated Relapse/Refractory (R/R) Acute Myeloïd Leukemia (AML), through occurrence of dose-limiting toxicity (DLT).
The primary objective of the second extension stage is to evaluate the efficacy of combining gilteritinib with the Gemtuzumab Ozogamicin (GO)-cytarabine AGORA platform in patients with FLT3-ITD and/or FLT3-TKD mutated Relapse/Refractory (R/R) Acute Myeloïd Leukemia (AML) through event-free survival (EFS).
| Arm | Type | Description |
|---|---|---|
| Gemtuzumab ozogamicine - Cytarabine - Gilteritinib | EXPERIMENTAL | For Gemtuzumab ozogamicine administrated during the induction phase at D1, D4 and D7, 3mg/m2/day (5mg max), IV, 2h of infusion. For Cytarabine during induction and consolidation phase at D1 to D5, 1000 mg/m2, IV, 2h of infusion. For Gilteritinib during induction phase from D10 for 14 consecutive days, per os, two doses level study with dose level 1 (80mg/d) in part 1 or dose level 2 (80 or 120mg/d depending of the result of part 1) in part 2. During consolidation (2 cycles max) from D8 for 14 consecutive days, per os, 120mg/d or reduced dose of 80 mg/kg is planned to be used in patients receiving concomitantly CYP3A4 inhibitors. During the maintenance (24 months max) dose level 2 (120mg/d), per os. |
| Name | Type | Description |
|---|---|---|
| Gemtuzumab ozogamicine - Cytarabine - Gilteritinib | COMBINATION_PRODUCT | See Arms description paragraph |
Inclusion Criteria: * Patients aged 18 years old or more * Confirmed diagnosis of R/R AML positive for CD33 antigen as determined locally by immunophenotyping according to routine practice, defined as: * AML refractory to 1 or 2 intensive chemotherapy courses or a treatment by hypomethylating ag...