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Also known as Gemtuzumab ozogamicine - Cytarabine - Gilteritinib
Gemtuzumab ozogamicine- Cytarabine- Gilteritinib · 1 trial · 2 indications
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...
Gemtuzumab ozogamicine-Cytarabine-Gilteritinib is an investigational combination being studied for the treatment of acute myeloid leukemia (AML), specifically in adults with FLT3-ITD and/or FLT3-TKD relapse/refractory (R/R) AML. It is currently in Phase 2 clinical development.
Gemtuzumab ozogamicine-Cytarabine-Gilteritinib is a combination therapy that includes gemtuzumab ozogamicin, an antibody-drug conjugate targeting CD33, and gilteritinib, a small molecule that targets FLT3 mutations. The combination is being studied in AML patients with FLT3-ITD and/or FLT3-TKD mutations.
Gemtuzumab ozogamicine-Cytarabine-Gilteritinib is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 2 clinical trial of this combination in adults with relapse/refractory AML.
Gemtuzumab ozogamicine-Cytarabine-Gilteritinib is in Phase 2 clinical development. It is an investigational combination and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.
Gemtuzumab ozogamicine-Cytarabine-Gilteritinib is being studied in a single Phase 2 trial, NCT05199051, which is active but not recruiting. The trial enrolls adults with FLT3-ITD and/or FLT3-TKD relapse/refractory AML and is being conducted in France.
Yes, Gemtuzumab ozogamicine-Cytarabine-Gilteritinib is also known as Gemtuzumab ozogamicine-Cytarabine-Gilteritinib. The combination includes gemtuzumab ozogamicin, cytarabine, and gilteritinib, and is being evaluated in AML.