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New drug combo aims to outsmart aggressive leukemia

NCT ID NCT02428543

Disease control Sponsor: Versailles Hospital 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial tests whether adding the targeted drug ponatinib to standard chemotherapy (cytarabine) can help prevent relapse in adults with a specific, high-risk genetic form of acute myeloid leukemia (FLT3-ITD AML) who are already in first remission. The study includes two age groups (18–60 and up to 70 years) and will first find the safest dose of ponatinib, then evaluate how well the combination works. The goal is to improve long-term survival for patients whose leukemia has a poor outlook with standard treatment alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ponatinib and cytarabine
What this could lead to
If successful, this combination could improve remission duration and survival for people with a high-risk genetic form of AML.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. Ponatinib can cause serious side effects like blood clots and liver problems.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

49 people

The number who actually took part.

Started

Jul 2013

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 years

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: 1. a. Patients aged 18 to 55-60 years: Cohort A b. Patients aged 55-60 to 70 years: Cohort B 2. Signed informed consent 3. Acute myeloid leukemia in first complete remission 4. Platelets ≥ 100 Giga/l; Neutrophils ≥ 1 Giga/l 5. Intermediate risk karyotype with FLT3-ITD activating mutant detected at diagnosis (mutant FLT3/wild-type allelic ratio higher than 10%) (appendix 16) 6. Induction with intensive chemotherapy, dose dense sequential induction or 3 + 7 like regimen (daunorubicin or idarubicin) for Cohort A and inclusion in the ALFA backbone for cohort B. 7. Pancreatic functions within the normal range 8. AST or ALT less or equal to 2.5 fold upper normal range, bilirubin less or equal to 1.5 fold upper normal range 9. Serum creatinine less or equal to 1.5 fold upper normal range 10. Two planned consolidation courses with high-dose cytarabine (HDAC, Cohort A) or intermediate dose cytarabine (IDAC, Cohort B). Exclusion Criteria: 1. Acute promyelocytic leukemia 2. Transformation of myeloproliferative or myelodysplastic syndromes 3. Known central nervous system involvement 4. Uncontrolled bacterial, viral or fungal infection 5. Other active malignancy 6. Previous episode of pancreatitis 7. Hypertriglyceridemia \> 4.5 g/L 8. Lipase \> 1.5 × ULN, amylase \> 1.5 x ULN not related to leukemia 9. QTc \> 470 ms (Bazett formula, see Appendix 1) 10. Patients at high or very high risk of cardiovascular disease with any of the following f) Established cardiovascular disease * Cardiac disease: * Congestive heart failure greater than class II NYHA or * Left ventricular ejection fraction (LVEF) \< 50% or * Unstable angina (anginal symptoms at rest) or * New onset angina (began within the last 3 months) or * Myocardial infarction, coronary/peripheral artery disease, congestive heart failure, cerebrovascular accident including transient ischemic attack within the past 12 months or * History of thrombolic or embolic events * Arrhythmias \- Any history of clinically significant cardiac arrhythmias requiring anti-arrhythmic therapy. g) Diabetes Mellitus untreated or not equilibrated with therapy h) Arterial Hypertension, * \- Uncontrolled hypertension defined as systolic blood pressure greater than 140 mmHg or diastolic pressure greater than 90 mmHg, despite optimal medical management and optimal measurement (http://www.has-sante.fr/portail/display.jsp?id=c\_272459) * \- Any history of hypertension with * Hypertensive encephalopathy * Posterior leucoencephalopathy * Aortic or artery dissection i) Familial dysplipidemia. j) Taking medications that are known to be associated with Torsades de Pointes (see Appendix 11)

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia, FLT3 internal tandem duplication

As listed by the trial registrant

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

Acute myeloid lukemia

Contacts and locations

Locations

  • CHRU Dupuytren

    Limoges, 87042, France

  • CHU Boulogne Sur Mer

    Boulogne-sur-Mer, 62321, France

  • CHU Nice, Hôpital Archet 1

    Nice, 06202, France

  • CHU d'Angers

    Angers, 49033, France

  • CHU de Besançon

    Besançon, 25030, France

  • CHU de Dijon

    Dijon, 21079, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • Centre Hospitalier René Dubos

    Pontoise, 95303, France

  • Centre Hospitalier René Huguenin

    Saint-Cloud, 92210, France

  • Centre Hospitalier de Meaux

    Meaux, 77104, France

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59322, France

  • Centre hospitalier de Versailles

    Le Chesnay, 78157, France

  • Chr Clemenceau

    Caen, 14033, France

  • Chu Amiens

    Amiens, 80054, France

  • Dr Abdelaziz CHAIB

    Aix-en-Provence, 13600, France

  • Dr Arnaud PIGNEUX

    Pessac, 33604, France

  • Dr Christian RECHER

    Toulouse, 31000, France

  • Dr Edouard RANDIAMALALA

    Bayonne, 64100, France

  • Dr Emilie LEMASLE

    Rouen, 76000, France

  • Dr Jacques DELAUNAY

    Nantes, 44000, France

  • Dr Laurence SANHES

    Perpignan, 66000, France

  • Dr Mario OJEDA-URIBE

    Mulhouse, 68000, France

  • Dr Regis COSTELLO

    Marseille, 13000, France

  • Dr Réda GARIDI

    Saint-Quentin, 02100, France

  • Dr Stéphanie HAÏAT

    Corbeil-Essonnes, 91100, France

  • Dr Thorsten BRAUN

    Bobigny, 93000, France

  • Hôpital Claude Huriez

    Lille, 59037, France

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Hôpital La Pitié Salpêtrière

    Paris, 75013, France

  • Hôpital Necker Enfants Malades

    Paris, 75743, France

  • Hôpital Saint Antoine

    Paris, 75751, France

  • Hôpital Saint Louis

    Paris, 75010, France

  • Hôpital VICTOR DUPOUY

    Argenteuil, 95107, France

  • Hôpital d'Instruction des Armées PERCY

    Clamart, 92141, France

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42270, France

  • Marc BERNARD

    Rennes, 35000, France

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