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

Launched by ORYZON GENOMICS S.A. · Sep 15, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment combination for patients with relapsed or refractory acute myeloid leukemia (AML) that has a specific genetic mutation known as FLT3. The study is testing a drug called iadademstat alongside gilteritinib, which is already approved for treating this type of leukemia. The goal is to see if this combination can help patients who have not responded to previous treatments or have experienced a relapse of their cancer.

To participate in this trial, patients need to have a confirmed diagnosis of AML that has either come back after treatment or has not responded to treatment. They must also have specific FLT3 mutations and meet other health criteria, like being able to swallow pills and having good liver and kidney function. Participants can expect to receive the new treatment and will be monitored closely by medical professionals throughout the trial. It’s important to note that certain health conditions and previous treatments might prevent someone from joining the study, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • 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
• • Life expectancy of at least 3 months in the opinion of the investigator.
• • Normal hepatic and renal function.
• • Patient is able to swallow oral medications.
• • Female patients are postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.
• • Male patients even if surgically sterilized agree to practice true abstinence or use highly effective barrier contraception.
• Main Exclusion Criteria:
• • 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.
• • Clinically active central nervous system leukemia or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.
• • Major surgery or radiation therapy within 4 weeks prior to the first study dose.
• • Prior treatment with iadademstat is not allowed. Treatment with any other agents with KDM1A/LSD1 inhibitory activity is only allowed if treatment finalized at least 3 weeks prior to first dose on study. Previous treatment with FLT3 inhibitors is allowed in the following cases: midostaurin and sorafenib are allowed when used in first-line therapy regimen as part of induction, consolidation and/or maintenance: quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as part of induction, consolidation and/or maintenance, ONLY if patients were not refractory to the drugs or if responding, relapse did not occur while on these drugs.
• • Patients not eligible to receive gilteritinib per label.
• • Prior treatment with 3 or more lines of AML therapy.
• • Treatment with any investigational products within 3 weeks prior to first dose of study treatment.
• • Uncontrolled hypertension or poorly controlled diabetes.
• • Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
• • Pregnant or lactating women.