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Can a Two-Drug combo in one liposome beat AML at first try?

NCT ID NCT05599360

Disease control Sponsor: Shaare Zedek Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This pilot trial tests whether Vyxeos, a liposomal formulation combining two chemotherapy drugs, can effectively treat newly diagnosed low- or intermediate-risk acute myeloid leukemia (AML) in adults aged 18 to 70. Some participants also receive Mylotarg, an antibody-drug conjugate, to see if adding it improves outcomes. The study measures remission rates, minimal residual disease, and safety. It aims to answer whether this approach works better than standard induction therapy for this patient group.

What this could mean

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

Active substance
Vyxeos (a liposomal combination of daunorubicin and cytarabine), given alone or with Mylotarg (gemtuzumab ozogamicin)
What this could lead to
If it works, this could point toward a more effective first treatment for adults with low- or intermediate-risk acute myeloid leukemia, potentially improving remission rates and survival.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply broadly. Combining Vyxeos with Mylotarg could raise the risk of severe side effects, and the trial may not confirm added benefit over standard care.

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

20 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Sep 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 70 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: 1. Diagnosis of AML (\>20% blasts in blood or BM) 2. Favorable or intermediate risk cytogenetics Exclusion criteria: 1. Acute promyelocytic leukemia with recurring translocations involving Retinoic Acid Receptor Alpha (RARA) 2. Acute leukemias of ambiguous lineage 3. Therapy-related myeloid neoplasms 4. Background of myelodysplastic syndrome or myeloproliferative neoplasm 5. FLT3-Internal tandem duplications (ITD) mutation with any allelic ratio 6. AML with Adverse cytogenetic risk (ELN 2017) 7. Eastern Cooperative Oncology Group (ECOG) performance status 3-4 8. Previous treatment with radiation therapy or cytotoxic chemotherapy (treatment with corticosteroids or hydroxyurea will not exclude the patient) 9. Age\<18 or \>70 10. Serum creatinine ≥ 2.0 mg/dl or creatinine clearance \< 50 ml/min within 14 days of registration 11. Direct bilirubin ≥2.0 g/dl, or alkaline phosphatase/ serum glutamic-oxaloacetic transaminase (SGOT) \> 4xupper limit of normal within 14 days of registration 12. Left ventricular ejection fraction (LVEF)\<45% 13. Pregnant or breastfeeding women 14. Blastic transformation of chronic myelogenous leukemia (CML) 15. Secondary AML (defined as prior chemotherapy-induced or evolved from myelodysplastic syndrome or myeloproliferative neoplasm)

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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.

Leukemia, myeloid, acute

Contacts and locations

Locations

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102, Israel

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