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Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

ConditionsAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOryzon Genomics S.A.

About this trial

Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)

Patient is in first or second relapse or has refractory disease. Patients must have had histologic verification of AML at the original diagnosis.

Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or FLT3-ITD and specified FLT3-TKD.

ECOG performance status 0-2

Disqualifiers

Diagnosis of acute promyelocytic leukemia.

Known BCR-ABL-positive leukemia.

AML secondary to prior chemotherapy for other neoplasms (except for MDS).

AML that has relapsed after or is refractory to more than 2 lines of therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Iadademstat

    Drug

    iadademstat oral solution

  • Gilteritinib Oral Tablet

    Drug

    120 mg Gilteritinib

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Active armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse Events (AE)

Number of participants with Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Time frame
Up to 18 months
2

Laboratory value abnormalities and/or adverse events (AE)

Number of participants with laboratory value abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Time frame
Up to 18 months
3

Vital sign abnormalities and/or adverse events (AEs)

Number of participants with vital signs abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Time frame
Up to 18 months
4

Routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

Number of participants with Routine 12-lead electrocardiogram (ECG )abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

Time frame
Up to 18 months

Secondary outcomes

1

Overall Survival (OS)

Time from start of treatment to the time of death from any cause.

Time frame
Up to 24 months
2

Event-Free-Survival (EFS)

Time from start of treatment to the date of failure to achieve CR or CRi, relapse from CR/CRi, or death from any cause, whichever occurs first.

Time frame
Up to 18 months
3

Overall response rate

Percentage of patients with complete remission (CR), CR with incomplete blood count recovery (CRi), or PR.

Time frame
Up to 6 months
4

Time to Response (TTR)

Time from the date of initial dosing at RP2D/expansion dose to first documentation of either a type of CR or Partial Response (PR).

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

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

Oryzon Genomics S.A.

Lead sponsor

Source ClinicalTrials.gov
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