Study of Gilteritinib with Chemotherapy in Children, Teens, and Young Adults with a Specific Type of Relapsed or Hard-to-Treat Acute Myeloid Leukemia (AML)

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04240002

Provider View

This clinical trial is testing a new treatment combining gilteritinib with chemotherapy for children, adolescents, and young adults who have a specific type of acute myeloid leukemia (AML) that has returned or is not responding to treatment. The study aims to find the best dose and see how well the treatment works.

Patient Parameters

Program Overview

The study is divided into two parts. The first part aims to find the safest and most effective dose of gilteritinib when combined with chemotherapy drugs fludarabine, cytarabine, and a growth factor called FLAG. The second part will look at how well this combination works in achieving complete remission after two treatment cycles. Each cycle lasts 28 days. Participants who complete one or two cycles may continue with gilteritinib treatment for up to two years. The study will also monitor the safety and side effects of the treatment, how well it inhibits the FLT3 gene, and the overall survival rates of participants.

Eligibility Criteria

Inclusion Criteria

  • Aged between 6 months and 21 years.
  • Diagnosed with acute myeloid leukemia (AML) with at least 5% cancer cells in the bone marrow.
  • For Phase 1: Must be in first or greater relapse or not responding to initial treatment.
  • For Phase 2: Must be not responding to or in first relapse after initial treatment.
  • Must have recovered from previous treatments.
  • Must meet specific health criteria, including liver and kidney function tests.
  • Women must not be pregnant and agree to use birth control during and after the study.
  • Men must agree to use birth control and not donate sperm during and after the study.
  • Must not participate in another interventional study while on treatment.
  • Must have a specific FLT3 mutation in bone marrow or blood.

Exclusion Criteria

  • Active leukemia in the central nervous system.
  • Uncontrolled heart problems or significant heart disease.
  • Active infections that are not improving with treatment.
  • Receiving other cancer treatments not specified in the study.
  • Active graft-versus-host disease (GVHD) or on certain immunosuppressive drugs.
  • Other active cancers besides AML.
  • Significant health issues that could affect safety or study participation.
  • Low potassium or magnesium levels that cannot be corrected.
  • Taking certain medications that affect liver enzymes.
  • Known HIV infection or active hepatitis B or C.
  • Allergic reactions to study drugs or their components.

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