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New targeted therapy shows promise in Tough-to-Treat leukemia

NCT ID NCT03182244

Disease control Sponsor: Astellas Pharma Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tested a new drug called ASP2215 against standard chemotherapy in 276 adults with a specific type of acute myeloid leukemia (FLT3-mutated) that had come back or not responded to initial treatment. The goal was to see if ASP2215 helped people live longer (overall survival) and kept the leukemia from progressing (event-free survival). Participants were randomly assigned to receive either ASP2215 or one of several chemotherapy options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

276 people

The number who actually took part.

Started

Oct 2017

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization (WHO) classification as determined by pathology review at the treating institution. * Participant is refractory to or relapsed after first-line AML therapy (with or without HSCT) * Refractory to first-line AML therapy is defined as: a. Participant did not achieve CR/CRi/CRp under initial therapy. A participant eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A participant not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this participant. * Untreated first hematologic relapse is defined as: 1. Participant must have achieved a CR/CRi/CRp with first-line treatment and has hematologic relapse. * Participant is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab. A participant with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on a local test performed after completion of the last interventional treatment. Participants can be enrolled from a local test result if the participants have any of the following FLT3 mutations: FLT3-internal tandem duplication (ITD), FLT3-tyrosine kinase domain (TKD)/D835 or FLT3-TKD/I836. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Participant is eligible for preselected salvage chemotherapy. * Participant must meet the following criteria as indicated on the clinical laboratory tests: * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) * Serum total bilirubin (TBL) ≤ 1.5 x ULN * Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of \> 50 mL/min as calculated by the Modification of Diet in Renal Disease equation. * Participant is suitable for oral administration of study drug. * Participant agrees not to participate in another interventional study while on treatment. Inclusion Criteria for COE: Participant is eligible for the COE if they continue to meet all inclusion criteria from the main protocol in addition to the following when the participant is evaluated for eligibility to participate in the COE portion of the study: * Participant has received study treatment of either LoDAC, MEC or FLAG and has no response or progressive disease. * Participant have not received other antileukemic therapy after EOT (hydroxyurea is allowed for the control of peripheral leukemic blasts in participants with leukocytosis). * Participant agrees not to participate in another interventional study while on treatment. Exclusion Criteria: * Participant was diagnosed as acute promyelocytic leukemia. * Participant has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis). * Participant has AML secondary to prior chemotherapy for other neoplasms (except for MDS). * Participant is in second or later hematologic relapse or has received salvage therapy for refractory disease. * Participant has clinically active central nervous system leukemia.. * Participant has been diagnosed with another malignancy, unless disease-free for at least 5 years. Participants with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Participants with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy. * Participant has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib and midostaurin used in first-line therapy regimen as part of induction, consolidation and/or maintenance). * Participant has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation. * Participant has had major surgery within 4 weeks prior to the first study dose. * Participant has radiation therapy within 4 weeks prior to the first study dose. * Participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram (ECHO) performed within 1 month prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%. * Participant with mean of triplicate Fridericia-corrected QT interval (QTcF) \> 450 ms at Screening based on central reading. * Participant with Long QT Syndrome at Screening. * Participant with hypokalemia and hypomagnesemia at Screening (defined as values below lower limit of normal \[LLN\]). * Participant requires treatment with concomitant drugs that are strong inducers of CYP3A. * Participant requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the participant. * Participant requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant. * Participant has an active uncontrolled infection. * Participant is known to have human immunodeficiency virus infection. * Participant has active hepatitis B or C or other active hepatic disorder. * Participant has any condition which makes the participant unsuitable for study participation. * Participant has active clinically significant (graft-versus-host disease) GVHD or is on treatment with systemic corticosteroids for GVHD. * Participant has an FLT3 mutation other than the following: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836. Exclusion Criteria for COE: Participant will be excluded from participation in the COE if they meet any of the exclusion criteria listed in the main protocol or when the participant is evaluated for eligibility to participate in the COE portion of the study.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AML with FLT3 mutation

Contacts and locations

Locations

  • Site CN101

    Tianjin, China

  • Site CN102

    Guangzhou, China

  • Site CN103

    Beijing, China

  • Site CN105

    Wuhan, China

  • Site CN106

    Qingdao, China

  • Site CN107

    Hangzhou, China

  • Site CN108

    Beijing, China

  • Site CN109

    Beijing, China

  • Site CN110

    Beijing, China

  • Site CN113

    Zhengzhou, China

  • Site CN114

    Guangzhou, China

  • Site CN116

    Changchun, China

  • Site CN117

    Jinan, China

  • Site CN118

    Hefei, China

  • Site CN119

    Fuzhou, China

  • Site CN120

    Changsha, China

  • Site CN121

    Guangzhou, China

  • Site CN122

    Xi'an, China

  • Site CN123

    Huangpu Qu, China

  • Site CN125

    Shenyang, China

  • Site CN126

    Shanghai, China

  • Site CN128

    Nanjing, China

  • Site CN129

    Shanghai, China

  • Site CN130

    Guiyang, China

  • Site CN131

    Beijing, China

  • Site CN132

    Zhangzhou, China

  • Site CN133

    Lanzhou, China

  • Site CN136

    Zhengzhou, China

  • Site MY301

    Johor Bahru, Malaysia

  • Site MY302

    Kuala Lumpur, Malaysia

  • Site MY303

    Pulau Pinang, Malaysia

  • Site MY304

    Kota Kinabalu, Malaysia

  • Site MY305

    George Town, Malaysia

  • Site MY306

    Ampang, Malaysia

  • Site RU501

    Saint Petersburg, Russia

  • Site RU502

    Saint Petersburg, Russia

  • Site RU504

    Krasnoyarsk, Russia

  • Site RU506

    Kemerovo, Russia

  • Site RU507

    Saint Petersburg, Russia

  • Site RU508

    Moscow, Russia

  • Site RU509

    Moscow, Russia

  • Site SG401

    Singapore, Singapore

  • Site SG402

    Singapore, Singapore

  • Site SG403

    Singapore, Singapore

  • Site TH201

    Khon Kaen, Thailand

  • Site TH202

    Khon Kaen, Thailand

  • Site TH203

    Bangkok, Thailand

  • Site TH204

    Chiang Mai, Thailand

  • Site TH205

    Bangkok, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.