Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Hope for kids with leukemia: new drug combo aims to boost remission

NCT ID NCT05955261

Disease control Sponsor: St. Jude Children's Research Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This phase 2 trial tests whether adding the targeted drug venetoclax to standard chemotherapy is safe and effective for children and young adults (up to age 22) with newly diagnosed acute myeloid leukemia (AML). The study aims to see if this combination can reduce the amount of cancer left after the first round of treatment. About 70 participants will receive different numbers of treatment cycles based on their risk level.

What this could mean

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

Active substance
Venetoclax (a targeted drug) combined with standard chemotherapy drugs (azacitidine, cytarabine, gemtuzumab ozogamicin)
What this could lead to
If successful, this could lead to a more effective treatment for pediatric AML, helping more children achieve remission with fewer remaining cancer cells.
What could go wrong
This is an early-phase trial with only 70 participants, so results may not apply to all patients. Adding venetoclax to chemotherapy may increase side effects, and the study is currently suspended, which may indicate safety or recruitment issues.

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 70 people

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

Started

Jul 2023

Expected to finish

Mar 2034

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

29 days to 21 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.

Patients with preexisting conditions that may affect chemotherapy tolerance (e.g., bone marrow failure syndrome, cardiac disease, pulmonary disease, and history of significant hepatic impairment) should be discussed with study PI in detail to enable review of the medical history prior to enrollment onto AML23 study. Inclusion Criteria: * Diagnosis of AML fulfilling the criteria of the WHO classification of myeloid neoplasms or \< 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality or myeloid sarcoma or primary myelodysplastic syndrome (MDS) with ≥ 10% blasts or a complete blood count with the presence of at least 1,000 blasts/μL (e.g., a WBC count ≥ 10,000/μL with ≥ 10% blasts or a WBC count ≥ 5,000/μL with ≥ 20% blasts * Age \> 28 days and \< 22 years * No prior therapy for this malignancy except for one dose of intrathecal therapy and hydroxyurea or low-dose cytarabine (≤ 200 mg/m\^2 per day for ≤ 7 days) * Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment * Male and female participants of reproductive potential must agree to use an effective contraceptive method during the study and for 6 months after study treatment * Written informed consent from the patient and/or parent/legal guardian * Direct bilirubin ≤ 1.5 x institutional upper limit of normal Exclusion Criteria: * Patients with treatment-related AML, Down syndrome, acute promyelocytic leukemia, chronic myeloid leukemia in blast crisis, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible * Uncontrolled systemic fungal, bacterial, or viral infection or significant concurrent disease that would compromise patient safety or compliance, study participation, follow up, or interpretation of study results * Prior exposure to any dose of anthracycline or anthracenedione * Patients may not receive strong or moderate CYP3A inducers, such as rifampin, within 3 days of enrollment * Patients may not receive moderate or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole) within 3 days of enrollment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome myelodysplastic syndrome with excess blasts-2 myeloid sarcoma

As listed by the trial registrant

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

Acute myeloid leukemia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ann & Robert H. Lurie Children's Hospital

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • Children's Hospital of Orange County

    SUSPENDED

    Orange, California, 92868, United States

  • Children's National Medical Center

    SUSPENDED

    Washington D.C., District of Columbia, 20020, United States

  • Cincinnati Children's Hospital Medical Center

    SUSPENDED

    Cincinnati, Ohio, 45229, United States

  • Cook Children's Medical Center

    SUSPENDED

    Fort Worth, Texas, 76104, United States

  • Dana-Farber Cancer Institute

    SUSPENDED

    Boston, Massachusetts, 02115, United States

  • Novant Health Presbyterian Medical Center

    SUSPENDED

    Charlotte, North Carolina, 28204, United States

  • Rady Children's Hospital-San Diego

    SUSPENDED

    San Diego, California, 92123, United States

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

  • Valley Children's Hospital

    SUSPENDED

    Madera, California, 93636, United States

More trials for these conditions

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