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Drug cocktail aims to tame advanced leukemia

NCT ID NCT03895671

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial is testing whether combining two drugs, ponatinib and 5-azacitidine, can improve survival in people with advanced chronic myeloid leukemia (CML). The study includes adults whose CML has progressed to an accelerated phase or a more aggressive blast crisis. Participants receive both drugs, and researchers track overall survival, safety, and how well the disease responds.

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 5-azacitidine
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced chronic myeloid leukemia, potentially improving survival and disease control.
What could go wrong
This is an early-phase trial with a small number of participants. The combination may cause side effects, and it is not yet known if it will be more effective than existing treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Started

Jun 2019

Finished

Dec 2025

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 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: 1. Patient aged 18 years or more 2. Signed informed consent 3. Patient with Philadelphia chromosome positive CML in first blast crisis or first accelerated phase: * AP-CML is defined by the presence of any of the following features: * 15-29% blasts in peripheral blood (PB) or bone marrow (BM) * ≥ 20% basophils in PB * ≥ 30% blasts plus promyelocytes (with blasts \<30%) in PB or BM, * \<100 x10(9)/L platelets unrelated to therapy, or by clonal cytogenetics evolution (i.e., the presence of cytogenetic abnormalities other than the Philadelphia chromosome); * MBC-CML is defined by the presence of ≥ 30% blasts in the bone marrow and/or peripheral blood or the presence of extramedullary disease. 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 5. Have adequate renal function as defined by the following criterion: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for institution 6. Have adequate hepatic function as defined by the following criteria: 1. Total serum bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome or CML 2. Alanine aminotransferase (ALT) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic infiltration of the liver is present 3. Aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN if leukemic infiltration of the liver is present 7. Have normal pancreatic status as defined by the following criterion: Serum lipase and amylase ≤ 1.5 × ULN 8. Have normal QTcF interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of ≤ 450 ms in males or ≤ 470 ms in females. 9. Have a negative pregnancy test documented prior to enrollment (for females of childbearing potential). 10. Agree to use an effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile). 11. Have fully recovered (≤ grade 1, returned to baseline, or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study drug Exclusion Criteria: 1. Pregnant or lactating women, 2. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment, 3. Prior history of hematopoietic stem cell transplantation 4. Cardiovascular disease: * Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. * Myocardial infarction within the previous 6 months * Symptomatic cardiac arrhythmia requiring treatment 5. Individuals with another active malignancy 6. Patients at high risk or very high risk of arterio-veinous occlusive disease defined by European CVD score 7. Previous treatment with azacitidine, 8. Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure) 9. Known active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C

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Conditions

The condition(s) this trial relates to.

blast phase chronic myelogenous leukemia, BCR-ABL1 positive leukemia, myeloid, accelerated-phase

As listed by the trial registrant

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

Chronic myelogenous leukaemia in accelerated phase Chronic myelogenous leukaemia in myeloid blast crisis

Contacts and locations

Locations

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Annecy Genevois

    Pringy, France

  • Centre Hospitalier D'Avignon

    Avignon, France

  • Centre Hospitalier Metropole Savoie

    Chambéry, France

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, France

  • Centre Hospitalier Universitaire D'Amiens

    Amiens, France

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand, France

  • Centre Hospitalier Universitaire de Dijon

    Dijon, France

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, France

  • Centre Hospitalier Universitaire de Limoges

    Limoges, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, France

  • Centre Hospitalier Universitaire de Rennes

    Rennes, France

  • Centre Hospitalier de Caen-Normandie

    Caen, France

  • Centre Hospitalier de La Cote Basque

    Bayonne, France

  • Centre Hospitalier de Perpignan

    Perpignan, France

  • Centre Hospitalier de Strasbourg

    Strasbourg, France

  • Centre Hospitalier de Versailles

    Versailles, France

  • Centre Leon Berard

    Lyon, France

  • Chru de Nancy

    Vandœuvre-lès-Nancy, France

  • Hopital Avicenne

    Bobigny, France

  • Hopital Bicetre

    Le Kremlin-Bicêtre, France

  • Hopital Henri Mondor

    Créteil, France

  • Hopital Pitie-Salpetriere

    Paris, France

  • Hopital St Antoine

    Paris, France

  • Hopital St Louis

    Paris, France

  • Hospices Civils de Lyon

    Pierre-Bénite, France

  • Institut Bergonie

    Bordeaux, France

  • Institut Universitaire Du Cancer Toulouse

    Toulouse, France

  • Intitut Gustave Roussy

    Villejuif, France