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New combo attack on leukemia shows promise in early trial

NCT ID NCT05306301

Disease control Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether adding the targeted drug ponatinib to standard chemotherapy can improve outcomes for adults with a specific, high-risk type of acute lymphoblastic leukemia called BCR/ABL1-like ALL. The study enrolls 32 patients aged 18-65 who have not yet been treated. The main goal is to see how many achieve a deep remission (MRD negativity) after three cycles of treatment.

What this could mean

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

Active substance
Ponatinib (a targeted drug that blocks cancer growth signals)
What this could lead to
If successful, this could offer a more effective first-line treatment for a hard-to-treat form of acute lymphoblastic leukemia, potentially improving remission rates.
What could go wrong
This is a small Phase 2 study (32 people) with no control group, so results may not be definitive. Ponatinib can cause serious side effects like blood clots, pancreatitis, 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 2

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

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jul 2028

An estimate. End dates often move.

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 65 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: * Age 18-65 years. * De novo Ph+-like ALL, as defined by the BCR/ABL1-like predictor (13). * WHO score ≤2. * Adequate liver function, as defined by the following criteria: total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, alanine aminotransferase (ALT) ≤2.5 × ULN or ≤2.5 x ULN or leukemia related. * Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN or leukemia related. * No history of dyslipidemia, thrombotic events or cardiac disease. * For females of childbearing potential, a negative pregnancy test must be documented. * Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 12 months after the end of treatment. * Signed informed consent, according to ICH/EU/GCP and national regulation. Exclusion Criteria: * WHO performance status \>2. * Active HBV or HCV hepatitis, or AST/ALT \> 2.5 x ULN and bilirubin \> 1.5 x ULN. * History of acute pancreatitis within 1 year of study or history of chronic pancreatitis. * History of alcohol abuse. * Ongoing or active infections. * Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL). * Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to: * Any history of myocardial infarction, stroke, or revascularization, unstable angina or transient ischemic attack within 6 months prior to enrollment, * Congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards, * History of clinically significant (as determined by the treating physician) atrial arrhythmia, * Any history of ventricular arrhythmia, * Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism. * Uncontrolled hypertension (diastolic blood pressure \>90 mm Hg; systolic \>140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control. * Taking medications that are known to be associated with torsades de pointes. * Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib. * Creatinine levels \> 2.5mg/dl or glomerular filtration rate (GFR) \< 20 ml/min or proteinuria \>3.5 g/day. * Gastrointestinal (GI) function impairment, or a GI disease that may significantly alter the absorption of study drugs. * Patients who are currently receiving treatment with any of the medications with potential to prolong QT interval (listed in Appendix F) if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. * Patients who have received any investigational drug ≤ 4 weeks. * Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. * Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs. prior to administration of Ponatinib). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ two effective reliable methods of birth control throughout the study and for up to 12 months following discontinuation of study drugs. * Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. * Patients unwilling or unable to comply with the protocol.

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Conditions

The condition(s) this trial relates to.

B-lymphoblastic leukemia/lymphoma, BCR-ABL1–like lymphoblastic leukemia, acute, with lymphomatous features Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Chemotherapy Leukemia, acute lymphoblastic

Contacts and locations

Locations

  • Dipartimento di Medicina Traslazionale e di Precisione - Ematologia

    Roma, Italy

  • Ematologi Presidio Ospedaliero Guglielmo da Saliceto

    Piacenza, Italy

  • Ematologia AO Ospedali Riuniti Villa Sofia Cervello

    Palermo, Italy

  • Ematologia AOU Careggi

    Florence, Italy

  • Ematologia AOU Federico II

    Naples, Italy

  • Ematologia AOU Maggiore della Carità

    Novara, Italy

  • Ematologia AOU Policlinico Tor Vergata

    Roma, Italy

  • Ematologia AOU Policlinico Vittorio Emanuele-Ferrarotto

    Catania, Italy

  • Ematologia AOU S.ORSOLA-MALPIGHI

    Bologna, Italy

  • Ematologia AOU Senese

    Siena, Italy

  • Ematologia ASST Papa Giovanni XXIII

    Bergamo, Italy

  • Ematologia ASST Spedali Civili

    Brescia, Italy

  • Ematologia Fondazione Policlinico San Matteo

    Pavia, Italy

  • Ematologia Ospedale Maggiore Policlinico

    Milan, Italy

  • Ematologia Ospedale Mauriziano

    Torino, Italy

  • Ematologia Ospedale S.Giovanni Battista Molinette

    Torino, Italy

  • Ematologia Ospedale V.Fazzi

    Lecce, Italy

  • Ematologia Ospedale dell'Angelo

    Mestre, Italy

  • Ematologia Policlinico A.Gemelli

    Roma, Italy

  • Ematologia Policlinico G.B. Rossi

    Verona, Italy

  • Ematologia Presidio Ospedaliero Infermi

    Rimini, Italy

  • Ematologia Presidio Ospedaliero Spirito Santo

    Pescara, Italy

  • Ematologia Presidio Ospedaliero Tortora

    Pagani, SA, Italy

  • Ematologia con Unità di Trapianto

    Avellino, AV, 83100, Italy

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