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Leukemia drug cocktail aims to boost remission in High-Risk patients

NCT ID NCT03455504

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests whether adding the targeted drug venetoclax to standard chemotherapy helps more adults with acute myeloid leukemia (AML) achieve remission. It enrolls people aged 18 to 65 with intermediate- or high-risk AML who have not yet been treated. The main goal is to see how many patients have no signs of leukemia after one or two rounds 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
venetoclax added to standard chemotherapy (fludarabine, cytarabine, idarubicin)
What this could lead to
If successful, this combination could improve remission rates for people with hard-to-treat acute myeloid leukemia.
What could go wrong
This is a mid-stage trial, so the added benefit of venetoclax is not yet proven. Side effects from the stronger drug combination may be significant.

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

124 people

The number who actually took part.

Started

Oct 2018

Finished

Jul 2026

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: * Patients with documented/confirmed new onset non-m3 acute myeloid leukemia, according to WHO 2017 will be eligible for this study. * Hematological illness has to be graded intermediate or high risk according ELN criteria * Patients ≥ 18 years old and ≤ 65 years old * ECOG performance status ≤ 2. * Patients with a life expectancy \>12 weeks * Patients may have AML which has arisen from prior therapies or other antecedent disorder * Adequate hepatic function * Adequate pancreatic function * Adequate renal function assessed by: Serum creatinine within reference laboratory ranges or creatinine clearance (by Cockcroft Gault formula, see Appendix 2) ≥ 50 mL/min for patients in whom, in the Investigator's judgment, serum creatinine level may not adequately reflect renal function. * All non-hematological adverse events must have resolved to NCI-CTCAE Grade ≤ 2 prior to starting therapy. * Patients must be considered by Investigator suitable to receive combination chemotherapy. * Combination chemotherapy has not to be considered toxic without expectation of any benefit for the patient * For females of childbearing potential, a negative pregnancy test must be documented within 72 hours prior to the first study drug administration. * All patients must be willing to use effective methods of contraception, during the treatment period and for 100 days after the last dose of Venetoclax. Female patients must be postmenopausal (≥ 1 year of amenorrhea), surgically sterile, or they must agree to use 2 adequate methods of contraception with at least one method with a failure rate of ≤ 1% per year (e.g., hormonal implants, combined oral contraceptives, vasectomized partner) and the second preferably a physical barrier method of contraception. Oral or injectable contraceptive agents cannot be the sole method of contraception. Male patients must be surgically sterile or agree to use an acceptable method of contraception. * Patient must be willing to submit the blood sampling and bone marrow sampling for the PK and PD analyses and exploratory biomarkers. * Ability to understand and willingness to sign an informed consent form. * Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Exclusion Criteria: * Patients with low risk AML according ELN criteria * Patients with current clinical evidence of CNS leukemia. * Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy with the exception of Hydroxyurea (HU) or 6-Mercaptopurine (6MP) in patients who need to continue this agent to maintain WBC count ≤10,000/mm3. HU and 6MP must be discontinued at the time of initiation of study medications. * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study including but not limited at: * unstable angina * Patients who are on anti-microbial agents with therapeutic intent

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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.

Acute myeloid leukemia

Contacts and locations

Locations

  • A.O.U. Careggi - Ematologia

    Florence, Italy

  • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche

    Salerno, Italy

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

    Torino, Italy

  • Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

    Bologna, Italy

  • Aou Senese - Uoc Ematologia E Trapianti

    Siena, Italy

  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

    Pagani, Italy

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza, Italy

  • Dipartimento Oncologico - Ospedale S. Maria delle Croci

    Ravenna, Italy

  • Dipartimento di Oncologia ed Ematologia S.C. -Città della Scienza di Torino San Giovanni Battista

    Torino, Italy

  • Ematologia - ASST Papa Giovanni XXIII

    Bergamo, Italy

  • Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia

    Milan, Italy

  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

    Pavia, Italy

  • Irccs Aou San Martino - Genova - Uo Clinica Ematologica

    Genova, Italy

  • Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia

    Rozzano, Italy

  • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori IRST

    Meldola, Italy

  • Ospedale Niguarda "Ca Granda" SC Ematologia

    Milan, Italy

  • Spedali Civili - Azienda Ospedaliera U.O. Ematologia

    Brescia, Italy

  • U.O. Ematologia e Trapianto di Midollo Ist. Scientifico Ospedale San Raffaele

    Milan, Italy

  • U.O.C. Ematologia e CTMO Az Ospedaliero Universitaria

    Parma, Italy

  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

    Roma, Italy

  • Università degli Studi "Sapienza" Dip. Biotecnologie Cellulari ed Ematologia

    Roma, Italy

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania, Italy

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