Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one prior line of AML directed therapy
Disqualifiers
Patients may not be receiving any other investigational agents
Patients with documented central nervous system involvement of AML
Progression of AML while on prior gilteritinib therapy
Patients must not have evidence of GI tract abnormalities that would alter the absorption of oral medications
Trial design
Treatments tested in this trial
- Gilteritinib
- Vyxeos
Treatment groups
22 Participants
are divided into 2 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Jazz Pharmaceuticals
Collaborator
Source ClinicalTrials.gov