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

ConditionAcute Myeloid Leukemia With FLT3/ITD Mutation
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Dose Escalation ArmExperimental treatment 2 interventions
Group B: Dose Expansion ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD)

Dose escalation will determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Vyxeos plus Gilteritinib. The MTD is the highest dose of the combination therapy that dose not cause unacceptable side effects.

Time frame
Up to 18 months

Secondary outcomes

1

Complete Remission Rate

Rate of complete remission (CR) and complete remission with incomplete blood count recovery (CRi). The definition of CR and CRi is based on the European LeukemiaNet 2017 Response Criteria

Time frame
Up to 18 months
2

Event free survival (EFS)

Event free survival is determined as the duration of time from start of treatment to the time of cancer recurrence.

Time frame
Up to 18 months
3

Overall survival (OS)

Overall survival is defined as the duration of time from start of treatment to the time of death from any cause or date of last contact.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Jazz Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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