Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05024552
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia With FLT3/ITD Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gilteritinib — DRUG
    Gilteritinib is an oral inhibitor of FLT3-ITD and FLT3-TKD. Dose cohort 1 will receive 120mg daily on days 6-19 of induction and days 4-17 of re-induction and consolidation
  • Vyxeos — DRUG
    Vyxeos is a liposomal encapsulation of cytarabine and daunorubicin. It is given as an intravenous infusion over 90 minutes on days 1, 3 and 5 of induction and days 1 and 3 of re-induction and consolidation. The induction and reinduction dose is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion. The consolidation dose is 29mg/m2 daunorubicin and 65mg/m2 of cytarabine with each dose.

Study Details

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

Key Dates

Start date
Feb 25, 2022
Status verified
Dec 2025
Primary completion
Feb 15, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Arm
    Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy. The induction and reinduction dose of Vyxeos is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion. Dose level 1: Vyxeos + 120 mg Gilertinib In the event of a dose-limiting toxicity (DLT) at the initial dose level, a dose level minus (-) 1 is permitted Dose Level -1: Vyxeos + 80 mg Gilertinib
  • Experimental: Dose Expansion Arm
    Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy in the dose determined in the dose escalation arm.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Jhada-Kai Hunter
[email protected]
813-745-0286
Onyee Chan, MD (PRINCIPAL_INVESTIGATOR)
Brandon Blue, MD (SUB_INVESTIGATOR)
Timothy Kubal, MD, MBA (SUB_INVESTIGATOR)
Andrew T Kuykendall, MD (SUB_INVESTIGATOR)
Jeffrey E Lancet, MD (SUB_INVESTIGATOR)
Eric Padron, MD (SUB_INVESTIGATOR)
David A Sallman, MD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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