Expanded Access Study of Gilteritinib for Patients with FLT3-Mutated Acute Myeloid Leukemia (AML)

Sponsor: Astellas Pharma Global Development, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03070093

Provider View

This study offers access to the drug Gilteritinib for patients with a specific type of leukemia (AML) that has returned or not responded to treatment, or is in remission with minimal residual disease.

Patient Parameters

Program Overview

The aim of this study is to provide the drug Gilteritinib to patients with a type of leukemia called FLT3-mutated AML, which has either come back after treatment or hasn't responded to treatment. It also includes patients whose leukemia is in remission but still shows minimal signs of disease. This is for patients who do not have access to other similar treatments.

Description

Gilteritinib (XOSPATA®) is approved by health authorities in the United States, Japan, and Canada for treating adults with a type of leukemia called FLT3-mutated AML that has returned or not responded to treatment. This study allows patients to receive Gilteritinib while other studies are ongoing.

Patients will have regular visits during the first cycle of treatment on days 1, 4, 8, and 15, then on days 1 and 15 of the second cycle, and on day 1 of every two cycles after that. Treatment will continue until the doctor decides it is no longer beneficial.

After stopping the treatment, patients will have a final visit within 7 days and a follow-up 30 days later. In Japan, patients in remission with minimal disease will not be included, and their response data will not be collected.

Eligibility Criteria

Inclusion Criteria

  • Must be an adult according to local laws.
  • Diagnosed with primary AML or AML that developed from another condition or treatment.
  • Have FLT3-mutated AML that has returned or not responded to treatment, or is in remission with minimal disease.
  • Must wait a certain period after stopping other treatments before starting Gilteritinib.
  • Must have normal liver and kidney function based on specific blood tests.
  • Must be able to take the medication by mouth.
  • If previously had a certain type of immune reaction, must meet specific criteria.
  • Women must not be pregnant and must use effective birth control during and after the study.
  • Men must use effective birth control and not donate sperm during and after the study.
  • Must not participate in another AML study while on this treatment.
  • HIV-positive patients can join if their condition is controlled.
  • No other suitable treatment options available.

Exclusion Criteria

  • Eligible for another ongoing study of Gilteritinib.
  • Have a heart condition that affects the heart's electrical activity.
  • Diagnosed with a different type of leukemia.
  • Have a significant blood clotting disorder not related to AML.
  • Have active hepatitis or liver disease.
  • Have severe heart problems.
  • Need to take certain medications that affect how Gilteritinib works.
  • Have any condition that makes participation unsuitable.
  • Allergic to any part of the study drug.

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