Quizartinib for Acute Myeloid Leukemia

Recruiting at 55 trial locations

Overseen By Contact for Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Daiichi Sankyo

Must not be taking: CYP3A inducers

Disqualifiers: APL, BCR-ABL leukemia, cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 87 months

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of two different doses of a drug called quizartinib for individuals with acute myeloid leukemia (AML). The focus is on those with a specific genetic marker (FLT3-ITD-positive) who are in their first complete remission after initial treatment. Participants must not have undergone a bone marrow transplant and should have completed their initial treatment phases. This trial may suit those who have finished their initial chemotherapy cycles and seek to maintain remission. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires a 14-day break from FLT3 inhibitors before starting. If you're on strong or moderate CYP3A inducers, you'll need to stop them 2 weeks before or 5 half-lives of the drug, whichever is longer. Other medications aren't specifically mentioned, so check with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that quizartinib has been tested for safety in people with acute myeloid leukemia (AML). In these studies, researchers used quizartinib alongside standard chemotherapy. The results indicated that quizartinib extended survival compared to a placebo (a pill with no active medicine).

While this is encouraging, awareness of possible side effects is important. The QuANTUM-First study examined the safety of quizartinib. Some patients experienced side effects like low blood cell counts, which can lead to infections or bleeding. Other side effects included nausea and changes in heart rhythm.

Overall, quizartinib has shown potential in treating AML, although side effects may occur. These findings can assist in deciding whether to join a clinical trial with quizartinib. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Quizartinib is unique because it specifically targets the FLT3 receptor, a common mutation in acute myeloid leukemia (AML) that contributes to cancer cell growth. While most current treatments for AML, like chemotherapy, attack rapidly dividing cells non-specifically, quizartinib offers a more precise approach by inhibiting this receptor, potentially reducing side effects and improving outcomes. Researchers are particularly excited about quizartinib's potential to enhance survival rates in patients with FLT3 mutations, offering hope for a more effective and tailored treatment option.

What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?

Studies have shown that quizartinib can help patients with acute myeloid leukemia (AML) live longer. Research indicates that combining quizartinib with standard chemotherapy improves overall survival without affecting patients' quality of life. In one study, 60.8% of patients treated with quizartinib were alive after three years, compared to 45.7% of those who received a placebo. Additionally, patients taking quizartinib were more likely to fully recover and experienced fewer treatment interruptions. These findings suggest that quizartinib is a promising treatment option for AML, especially for those with FLT3 mutations. Participants in this trial will receive either a higher or lower dose of quizartinib to further evaluate its effectiveness and safety. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of blood cancer called FLT3-ITD (+) acute myeloid leukemia who are in their first complete remission. They should have had 1-2 cycles of induction therapy and up to 4 consolidation treatments, but no stem cell transplant. Participants need to start maintenance within 60 days after the last treatment cycle.

Inclusion Criteria

I can use FLT3 inhibitors during my initial or follow-up cancer treatment.

I can start the next treatment phase within 60 days after finishing my last treatment cycle.

My blood counts meet the required levels for neutrophils and platelets.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive quizartinib as maintenance therapy after induction/consolidation

Up to 87 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Quizartinib

Trial Overview The study tests two different doses of Quizartinib as maintenance therapy for AML patients in remission. It's designed to see which dose is more effective at keeping the cancer from returning. Patients will be randomly assigned to receive either a low or high dose.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Participants will receive lower dose of quizartinib

Group II: Arm 1 Experimental Treatment 1 Intervention

Participants will receive higher dose of quizartinib

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-01841

Quizartinib for Newly Diagnosed FLT3-ITD–Negative Acute ... Median OS was not reached and 29.3 months in the quizartinib and placebo arms, respectively (P=0.012); three-year OS rates were 60.8% and 45.7%.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41082703/

Quizartinib for Newly Diagnosed FLT3-ITD-Negative Acute ... Median OS was not reached and 29.3 months in the quizartinib and placebo arms, respectively (P=0.012); three-year OS rates were 60.8% and 45.7%.

3. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/918/499415/Patient-Reported-Outcomes-in-Acute-Myeloid

Patient-Reported Outcomes in Acute Myeloid Leukemia ... Quizartinib showed improvement in OS without any detrimental impact on quality of life and symptoms when added to standard chemotherapy ...

4. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper205931.html

4282 Real-World Treatment Patterns and Effectiveness of ... Patients treated with 7+3+quizartinib were more likely to achieve CRc, less likely to experience TKI dosing interruptions, and less likely to ...

5. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-024-01617-7

Quizartinib: a potent and selective FLT3 inhibitor for the ... There was also a nonstatistically significant improvement in median EFS (secondary endpoint) in patients treated with quizartinib (1.4 months) ...

6. plainlanguagesummaries.com plainlanguagesummaries.com/evaluating-the-effectiveness-and-safety-of-quizartinib-with-chemotherapy-in-flt3-itd-positive-acute-myeloid-leukemia-a-plain-language-summary-of-the-quantum-first-study/

Effectiveness and safety of quizartinib with chemotherapy ... The QuANTUM-First study, published in The Lancet in April 2023, investigated the effectiveness of quizartinib combined with standard treatments for 539 adults.

7. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.1353

Safety and Pharmacokinetics of Quizartinib Combination ... It has shown improved overall survival in a randomized, multinational, Phase 3 (QuANTUM-First) study in patients with FLT3-internal tandem ...