UnknownPhase 2

Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD

Hong Kong40 participantsStarted 2017-10-01

Plain-language summary

The study aims to test if combination of quizartinib (AC220) and omacetaxine mepesuccinate (OM, also known as homoharringtonine) results in durable composite complete remission (CRc) in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML) carrying FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of written informed consent approved by the Institutional Review Board (IRB).
. Age ≥18 years
. Documented primary AML or AML secondary to myelodysplastic syndrome (MDS), as defined by World Health Organization criteria
. At diagnosis or in morphological relapse after an initial remission or refractory after induction chemotherapy, with or without HSCT
. Documentation of FLT3-ITD in BM or blood with allelic burden of ≥ 20% as determined by the study site laboratory
. ECOG performance score 0-2
. Discontinuation of prior AML treatment ≥ 2 weeks before the start of QUIZOM (except hydroxyurea or other treatment to control leukocytosis).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete remission

Timeframe: up to 16 weeks

Trial details

NCT IDNCT03135054

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-01

View on ClinicalTrials.gov More AML trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of written informed consent approved by the Institutional Review Board (IRB).
. Age ≥18 years
. Documented primary AML or AML secondary to myelodysplastic syndrome (MDS), as defined by World Health Organization criteria
. At diagnosis or in morphological relapse after an initial remission or refractory after induction chemotherapy, with or without HSCT
. Documentation of FLT3-ITD in BM or blood with allelic burden of ≥ 20% as determined by the study site laboratory
. ECOG performance score 0-2
. Discontinuation of prior AML treatment ≥ 2 weeks before the start of QUIZOM (except hydroxyurea or other treatment to control leukocytosis).

Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria