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Chemotherapy for Acute Myeloid Leukemia (QuANTUM-First Trial)

Q: What are the most popular conditions that Quizartinib is used to alleviate?

<p>Acute myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, pediatric is often treated with Quizartinib. Quizartinib is also useful for treating other conditions including leukemia, myelocytic, acute, blast phase chronic myelocytic leukemia, and <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>.</p>

Phase 3

Waitlist Available

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)

Awards & highlights

QuANTUM-First Trial Summary

This trial is testing whether quizartinib can help people with AML live longer.

Eligible Conditions

Acute Myeloid Leukemia
Leukemia

QuANTUM-First Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 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

Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Secondary outcome measures

Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Leukemia, Myelocytic, Acute

Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

+6 more

QuANTUM-First Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Chemotherapy plus quizartinibExperimental Treatment2 Interventions

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with the experimental drug quizartinib

Group II: Chemotherapy plus placeboActive Control2 Interventions

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Quizartinib

2016

Completed Phase 3

~1110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor

392 Previous Clinical Trials

410,826 Total Patients Enrolled

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

414,758 Total Patients Enrolled

Global Clinical LeaderStudy DirectorDaiichi Sankyo

162 Previous Clinical Trials

78,599 Total Patients Enrolled

Frequently Asked Questions

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

What are some other instances in which Quizartinib has been tested in a controlled setting?

"As of now, there are a total of 285 trials underway evaluating the efficacy of Quizartinib. Out of these, 68 are large-scale Phase 3 trials. Though the majority of these trials are based in Providence, Rhode island, there are 12559 medical centres running Quizartinib trials across the globe."

Answered by AI

Are there any medical conditions which would make an individual ineligible for this trial?

"This study is open to leukemia patients that are between 18-75 years old. 539 people in total will be able to join the trial."

Answered by AI

Are we able to enroll new participants at this time?

"As of now, this clinical trial is not looking for more patients. The trial was first posted on 2016-09-01 and updated for the last time on 2022-09-27. For those who are still searching for trials, there are presently 1586 clinical trials actively searching for participants with leukemia and 285 trials for Quizartinib actively recruiting participants."

Answered by AI

Are there long-term effects for patients that take Quizartinib?

"There is some clinical evidence to support the efficacy of Quizartinib, as well as data collected from multiple rounds of safety testing. Consequently, our team has given Quizartinib a safety score of 3."

Answered by AI

At how many different medical institutions is this research project being conducted?

"Right now, this trial is looking for participants from 15 different enrolment sites. These locations include Lexington, Hackensack and Durham. However, there are 12 other sites too. If you decide to join this trial, try and select a centre close to your home to limit travel."

Answered by AI

What are the most popular conditions that Quizartinib is used to alleviate?

"Acute myeloid leukemia, pediatric is often treated with Quizartinib. Quizartinib is also useful for treating other conditions including leukemia, myelocytic, acute, blast phase chronic myelocytic leukemia, and lymphoma."

Answered by AI

Can people who are over 30 years old participate in this research?

"Eligibility for this clinical study includes being between 18-75 years old, as specified in the inclusion criteria."

Answered by AI

How many individuals are being treated as part of this experiment?

"Unfortunately, this specific trial is not currently looking for new participants. Although, it is important to note that the study was last updated on September 27th, 2022. Additionally, there are 1586 other trials for leukemia and 285 trials for Quizartinib actively recruiting patients."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Quizartinib, an FLT3 Inhibitor, as Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukaemia: An Open-label, Multicentre, Single-arm, Phase 2 Trial

Cortes, Jorge, Alexander E Perl, Hartmut Döhner, Hagop Kantarjian, Giovanni Martinelli, Tibor Kovacsovics, Philippe Rousselot, et al.. 2018. “Quizartinib, an FLT3 Inhibitor, as Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukaemia: An Open-label, Multicentre, Single-arm, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30240-7.

The Lancet OncologyJournal

Quizartinib, an FLT3 Inhibitor, as Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukaemia: An Open-label, Multicentre, Single-arm, Phase 2 Trial

clinicaltrials.govStudy

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

2016. "Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02668653.