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Tyrosine Kinase Inhibitor

Quizartinib for Acute Myeloid Leukemia

Q: Are there any specific types of people who would be ideal candidates for this research?

<p>This study is testing a new medication for <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myeloid. The ideal candidate is 1 month to 21 years old and there are 65 spots available.</p>

Phase 1 & 2

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has protocol-defined adequate renal, hepatic and cardiac functions

In first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior HSCT is permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up re-induction phase 1 and 2,cycle 1: days 6, 20:predose, 1 hour (phase 1 only), 2, 4, and 6 hours; days 7 and 21:24 hours; phase 1 and 2 cycle 2: days 6 and 20:predose, 3 hours; continuation cycle 1 days 1 and 15:predose, 2-4 hours (each cycle, 28 days)

Awards & highlights

Study Summary

This trial is for an experimental drug and is only for children or young adults with FLT3-ITD AML that has come back or is not responding to treatment.

Who is the study for?

This trial is for children and young adults aged 1 month to 21 years with a specific blood cancer (FLT3-ITD AML) that's returned or isn't responding to treatment. They must have tried no more than one remission induction, be in good health otherwise, and agree to use effective birth control.Check my eligibility

What is being tested?

The study tests Quizartinib, an experimental drug not yet approved for regular use, alongside other chemotherapy drugs like Fludarabine and Cytarabine. It targets patients whose leukemia has relapsed or is resistant to initial treatments.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system, issues affecting organs such as kidneys or liver due to toxicity of the drugs, fatigue from chemotherapy, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney, liver, and heart are functioning well.

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My cancer returned after one high-dose chemo treatment, but I haven't tried more than once to achieve remission.

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I have been diagnosed with AML with at least 5% blasts in my bone marrow.

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My cancer has the FLT3-ITD mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ re-induction phase 1 and 2,cycle 1: days 6, 20:predose, 1 hour (phase 1 only), 2, 4, and 6 hours; days 7 and 21:24 hours; phase 1 and 2 cycle 2: days 6 and 20:predose, 3 hours; continuation cycle 1 days 1 and 15:predose, 2-4 hours (each cycle, 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~re-induction phase 1 and 2,cycle 1: days 6, 20:predose, 1 hour (phase 1 only), 2, 4, and 6 hours; days 7 and 21:24 hours; phase 1 and 2 cycle 2: days 6 and 20:predose, 3 hours; continuation cycle 1 days 1 and 15:predose, 2-4 hours (each cycle, 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and re-induction phase 1 and 2,cycle 1: days 6, 20:predose, 1 hour (phase 1 only), 2, 4, and 6 hours; days 7 and 21:24 hours; phase 1 and 2 cycle 2: days 6 and 20:predose, 3 hours; continuation cycle 1 days 1 and 15:predose, 2-4 hours (each cycle, 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite complete remission (CRc) rate among participants with acute myeloid leukemia (AML) (Phase 1 and 2)

Number of dose-limiting toxicities (Phase 1)

Pharmacokinetic parameter apparent clearance (CL/F) for quizartinib and AC886 (Phase 1 and 2)

+2 more

Secondary outcome measures

Acceptability of including the palatability of quizartinib formulations among participants with AML (Phase 1 and 2)

Complete remission (CR) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)

Complete remission (CR) rate among participants with AML (Phase 1 and 2)

+13 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment5 Interventions

All participants will receive re-induction therapy that includes fludarabine and cytarabine in combination with experimental drug quizartinib. For prophylaxis, IT chemotherapy with cytarabine, methotrexate and prednisolone/hydrocortisone will be given prior to or between re-induction cycles. After completing re-induction therapy, eligible participants may also receive optional consolidation chemotherapy which includes cytarabine, etoposide and quizartinib, if HSCT is not available immediately. After completing re-induction or HSCT successfully, eligible participants can go on to receive continuation therapy with quizartinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Quizartinib

2016

Completed Phase 3

~1110

Cytarabine

2016

Completed Phase 3

~3310

Etoposide

2010

Completed Phase 3

~2440

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupNETWORK

454 Previous Clinical Trials

237,875 Total Patients Enrolled

Daiichi SankyoLead Sponsor

392 Previous Clinical Trials

411,300 Total Patients Enrolled

Innovative Therapies For Children with Cancer ConsortiumOTHER

12 Previous Clinical Trials

2,033 Total Patients Enrolled

Media Library

Quizartinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03793478 — Phase 1 & 2

Acute Myeloid Leukemia Research Study Groups: All Participants

Acute Myeloid Leukemia Clinical Trial 2023: Quizartinib Highlights & Side Effects. Trial Name: NCT03793478 — Phase 1 & 2

Quizartinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03793478 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other scientific papers which discuss IT triple chemotherapy as a preventative measure?

"849 ongoing medical trials are researching IT triple chemotherapy prophylaxis, with the majority of these being in phase 3. The 146 Phase 3 trials for this medication are based primarily in Seattle, Washington; however, there are 24244 total locations running research studies on IT triple chemotherapy prophylaxis."

Answered by AI

What is the recruitment goal for this research project?

"In order to successfully carry out this clinical trial, 65 patients that fit the inclusion criteria are required. The sponsor, Daiichi Sankyo, Inc., has selected multiple locations for conducting the trial; two hospitals being UPMC Children's Hospital of Pittsburgh in Pittsburgh, Pennsylvania and Loma Linda University Cancer Center in Loma Linda, California."

Answered by AI

Are there any specific types of people who would be ideal candidates for this research?

"This study is testing a new medication for leukemia, myeloid. The ideal candidate is 1 month to 21 years old and there are 65 spots available."

Answered by AI

Does this experiment have an age limit?

"In order to be included in this particular trial, patients must fall between the ages of 1 month and 21. Out of the 773 trials for patients under 18 and 1886 trials for patients over 65, this is the specific one they qualify for."

Answered by AI

Are there many facilities conducting this research within the boundaries of our state?

"Enrolling patients can be found at 21 locations, which include UPMC Children's Hospital of Pittsburgh in Pittsburgh, Loma Linda University Cancer Center in Loma Linda, British Columbia Children's Hospital in Vancouver, as well as 18 other sites."

Answered by AI

Is this research study still enrolling patients who wish to participate?

"The study, which began recruitment on August 15th 2018 according to clinicaltrials.gov, is still looking for participants."

Answered by AI

What does IT triple chemotherapy prophylaxis typically prevent?

"While commonly used to treat merkel cell cancer, Intrathecal (IT) triple chemotherapy prophylaxis has also shown efficacy against meningeal leukemia, prostate cancer, and small cell lung cancer (sclc)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

2018. "Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03793478.

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