Study on the Safety and Effectiveness of Quizartinib for Children and Young Adults with Acute Myeloid Leukemia (AML)

Sponsor: Daiichi Sankyo

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03793478

Provider View

This clinical trial is testing an experimental drug called Quizartinib to see if it is safe and effective for children and young adults with a specific type of blood cancer, known as FLT3-ITD AML, that has returned or is not responding to treatment.

Patient Parameters

Program Overview

Quizartinib is a new drug being tested in this study. It is not yet approved for general use and is only available through research. The study is for children and young adults with a type of blood cancer called FLT3-ITD AML, which has either come back after treatment or is not responding to current treatments.

Description

This study is for children and young adults aged 1 month to 21 years who have a type of blood cancer called FLT3-ITD AML that has returned or is not responding to treatment. The study will be conducted in several phases to determine the best dose of Quizartinib for young patients.

Study Phases:

  • Dose Escalation/De-escalation Phase: Participants will be grouped by age to find the best dose of Quizartinib that is similar to the dose used in adults.

  • Dose-Expansion Phase: Participants will receive the determined dose of Quizartinib for their age group.

During these phases, participants will receive additional treatments:

  • Re-Induction Therapy: Includes chemotherapy and Quizartinib.

  • Stem Cell Transplantation Period: After initial therapy, participants may be eligible for a stem cell transplant. If a transplant is not immediately available, they may receive additional chemotherapy with or without Quizartinib.

  • Continuation Therapy: Participants who are in remission after a transplant or achieve partial remission will continue to receive Quizartinib for up to 12 cycles.

  • Long-term Follow-up: After completing Quizartinib therapy, participants will have follow-up visits every 3 months for 2 years, then annually to monitor their health and any further treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with AML with at least 5% cancer cells in the bone marrow.
  • Cancer has returned or is not responding to initial treatment.
  • Has the FLT3-ITD mutation in bone marrow or blood.
  • Aged between 1 month and 21 years.
  • Good overall health and organ function.
  • Recovered from previous cancer treatments.
  • Agree to use effective birth control if of reproductive age.
  • Females must test negative for pregnancy and not breastfeed.
  • Understands the study and agrees to participate.

Exclusion Criteria

  • Has certain types of leukemia or other blood disorders.
  • Has serious heart problems.
  • Has an active infection that is not improving.
  • Has active liver disease or HIV.
  • Allergic to study medications.
  • Receiving other cancer treatments not specified in the study.
  • Has other serious health issues that could affect participation.
  • Participating in another clinical trial.

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