Trials / Active Not Recruiting
Active Not RecruitingNCT05199051
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
AGORA-1 /ALFA 2100 Study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Centre Antoine Lacassagne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose of cytarabine and a divided dose of GO in adult patients with R / R AML with an FLT3-ITD and/or FLT3-TKD mutation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Gemtuzumab ozogamicine - Cytarabine - Gilteritinib | See Arms description paragraph |
Timeline
- Start date
- 2023-06-03
- Primary completion
- 2028-07-10
- Completion
- 2028-07-10
- First posted
- 2022-01-20
- Last updated
- 2026-01-05
Locations
12 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05199051. Inclusion in this directory is not an endorsement.