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Can gentler therapy beat harsh chemo for tough leukemia?

NCT ID NCT06713837

Disease control Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether less intense drug combinations can control relapsed or refractory acute myeloid leukemia (AML) as well as high-dose chemotherapy. About 339 adults whose AML has returned or not responded to initial treatment will be randomly assigned to either a low-intensity or high-intensity regimen. The study aims to see which approach improves event-free survival and overall survival with fewer side effects.

What this could mean

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

Active substance
chemotherapy drugs (cytarabine, mitoxantrone, etoposide, fludarabine, idarubicin, cladribine, amsacrine, daunorubicin) and targeted therapies (venetoclax, gilteritinib, azacitidine, decitabine)
What this could lead to
If successful, this could show that less intense treatments work as well or better than harsh chemotherapy for relapsed AML, potentially improving quality of life.
What could go wrong
This is a large phase 3 trial, but results may not apply to all AML subtypes. Both treatment arms have significant side effects, and the study is open-label, which could introduce bias.

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

About 339 people

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

Started

Feb 2025

Expected to finish

Jan 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 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: * Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria * 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022 * Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician * Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice * No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to: i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization * Male or Female, aged\>18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<4 * A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. * Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: * Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment) * Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization * Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia disease Recurrence

As listed by the trial registrant

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

Acute myeloid leukemia Relapse/recurrence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A. O. Ordine Mauriziano

    RECRUITING

    Torino, TO, 10128, Italy

  • AOU Careggi

    RECRUITING

    Florence, 50019, Italy

  • AOU Città della Salute e della Scienza di Torino

    RECRUITING

    Torino, TO, 10126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • ASST Valle Olonda

    RECRUITING

    Busto Arsizio, 21052, Italy

  • ASST degli Spedali Civili

    RECRUITING

    Brescia, 25123, Italy

  • Azienda Ospedale-Università Padova

    RECRUITING

    Padova, 35100, Italy

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Delle Marche

    RECRUITING

    Ancona, 60126, Italy

  • Azienda Ospedaliero-Universitaria Senese

    RECRUITING

    Siena, 53100, Italy

  • Azienda Unita Sanitaria Locale Di Piacenza

    RECRUITING

    Piacenza, 29121, Italy

  • Casa Sollievo Della Sofferenza

    RECRUITING

    San Giovanni Rotondo, 71013, Italy

  • Consorcio Hospital General Universitario De Valencia

    NOT_YET_RECRUITING

    Valencia, 46014, Spain

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo

    NOT_YET_RECRUITING

    Pavia, 27100, Italy

  • Fundeni Clinical Institute

    RECRUITING

    Bucharest, 022328, Romania

  • Heinrich-Braun-Klinikum gGmbH

    RECRUITING

    Zwickau, 08060, Germany

  • Hospital Clinico Universitario De Valencia

    NOT_YET_RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario De Albacete

    NOT_YET_RECRUITING

    Albacete, 02006, Spain

  • Hospital General Universitario Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hospital Universitari Vall D Hebron

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hospital de Santa Maria

    RECRUITING

    Lisbon, 1649-035, Portugal

  • IRCCS Ospedale Policlinico San Martino

    NOT_YET_RECRUITING

    Genova, GE, 16132, Italy

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genova, GE, 16132, Italy

  • IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    RECRUITING

    Meldola, 47014, Italy

  • Instituto de Investigación Sanitaria La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Istituto Oncologico Veneto IRCCS

    RECRUITING

    Castelfranco Veneto, 31033, Italy

  • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

    RECRUITING

    Halle, 06110, Germany

  • Ospedale Infermi

    RECRUITING

    Rimini, 47923, Italy

  • Ospedale S.Spirito - ASL Pescara

    NOT_YET_RECRUITING

    Pescara, PE, 65124, Italy

  • Ospedale San Bortolo

    RECRUITING

    Vicenza, 36100, Italy

  • Ospedale Santa Maria della Misericordia

    RECRUITING

    Perugia, PG, 06156, Italy

  • Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, RA, 48121, Italy

  • Ospedali Riuniti Villa Sofia - Cervello

    RECRUITING

    Palermo, PA, 90146, Italy

  • Policlinico Sant'Orsola

    RECRUITING

    Bologna, BO, 40138, Italy

  • Policlinico Tor Vergata

    RECRUITING

    Roma, RM, 00133, Italy

  • Policlinico Umberto I

    RECRUITING

    Roma, RM, 00161, Italy

  • The Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    RECRUITING

    Kaunas, 50161, Lithuania

  • Uniklinik RWTH Aachen

    RECRUITING

    Aachen, 52074, Germany

  • University Hospital Brno

    RECRUITING

    Brno, 625 00, Czechia

  • University Hospital Greifswald

    RECRUITING

    Greifswald, 17475, Germany

  • University Hospital Halle

    RECRUITING

    Halle, 06120, Germany

  • University Hospital Hradec Králové

    NOT_YET_RECRUITING

    Hradec Králové, 500 05, Czechia

  • University Hospital Olomouc

    NOT_YET_RECRUITING

    Olomouc, 779 00, Czechia

  • University Hospital in Ostrava

    NOT_YET_RECRUITING

    Ostrava, 708 00, Czechia

  • University Hospital in Pilsen

    RECRUITING

    Pilsen, 323 00, Czechia

  • University Hospital of Rostock

    RECRUITING

    Rostock, 18507, Germany

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