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New drug combo aims to beat back relapsed leukemia

NCT ID NCT06788756

Disease control Sponsor: Moleculin Biotech, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Updated 3 times

Summary

This study tests a new chemotherapy drug, L-Annamycin, combined with standard cytarabine in adults with acute myeloid leukemia (AML) that has come back or not responded to first treatment. About 312 participants will receive either the new drug combo or a placebo plus cytarabine. The goal is to see if L-Annamycin helps more people achieve complete remission after one cycle 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
L-Annamycin (a chemotherapy drug) combined with cytarabine
What this could lead to
If successful, this could offer a new second-line treatment option for adults with AML that has not responded to or returned after initial therapy.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove more effective than placebo. Chemotherapy side effects like infection and organ damage are possible.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 312 people

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

Started

Mar 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 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. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML. The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN's 2022 recommendations 2. Has refractory/relapsed AML after having received only one prior line of therapy\*. \*A prior line of therapy will be defined as the planned therapy consisting of one or more cycles of episodic treatment or a defined period of continuous treatment. This may consist of single-agent or combination therapy as well as a planned sequence of treatment phases. For example, first-line treatment of AML with induction, consolidation, and alloHSCT is considered one line of therapy. A line of therapy ends when the patient fails to achieve a response within a prespecified period (refractory) or relapses after achieving CR. For the purpose of confirming refractory AML at screening, refractory disease will be defined as CR not being achieved after first line therapy \[i.e., after 1 cycle of intensive therapy or 180 days after commencing less-intensive therapy (shorter durations of less-intensive therapy may be considered for refractory disease on a case by case basis after discussion between the PI and Medical Monitor)\]. 3. Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF). 4. Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first randomized dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control white blood cell (WBC) count, supportive measures, and prophylaxes as required under the protocol will be allowed. Treatment of opportunistic or other infections with antibiotics, antifungals, and/or antiviral agents, including therapy for meningeal disease (i.e., intrathecal chemotherapy), per institutional standards of care will be allowed during this period, as long as the symptoms of infection have resolved by 1 week prior to the first dose of randomized study drug. 5. Has received no investigational therapy within 4 weeks prior to the first randomized dose of study drug. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening. 7. Has a life expectancy of greater than six weeks at screening. 8. Has adequate laboratory results at screening including the following: 1. Total bilirubin ≤2.0 times the upper limit of normal (ULN). For subjects with leukemic involvement or Gilbert Syndrome, total bilirubin must be ≤3.0 ULN. 2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \<3.5 times the ULN. For subjects with organ involvement, AST, ALT, and alkaline phosphatase must be ≤4.5 times the ULN. 3. Creatinine clearance ≥60 mL/min (using Cockcroft-Gault equation). 9. Can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol. 10. For women of childbearing potential (WCBP): Must have a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test within 72 hours prior to the first randomized dose of study drug. 11. For WCBP: Must agree to not donate ova and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug. 12. For males with partners who are WCBP: Must agree to not donate sperm and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug. Exclusion Criteria: 1. Has prior or current diagnosis of acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML 2. Received prior mediastinal radiotherapy. 3. Has central nervous system involvement. 4. Has impaired cardiac function, including any of the following: 1. Abnormal LVEF at screening \[per American College of Cardiology, normal LVEF is 50 to 70% 2. Valvular heart disease. 3. Severe, uncontrolled hypertension. 4. Uncontrolled cardiac arrhythmias. 5. Recent (≤6 months prior to screening) myocardial infarction. 6. Unstable angina. 7. Symptomatic congestive heart failure. 8. New York Heart Association (NYHA) classification of 3 or 4. 9. QT interval/corrected QT (QTc) interval \>480 msec at screening. 10. History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). 11. . Use of concomitant medications with known risk of Torsades de Pointes (TdP) (i.e., drugs that prolong the QT interval and that are clearly associated with a known risk of TdP, even when taken as recommended; refer to Appendix G for examples of such drugs), unless in the clinical judgement of the PI, the medication is imperative and can be used safely with adequate monitoring. 5. Has clinically relevant serious comorbid medical conditions including, but not limited to, active infection, chronic obstructive or chronic restrictive pulmonary disease, history of positive status for human immunodeficiency virus (virus detected in serum) hepatitis B or hepatitis C with current serious symptoms or signs of underlying chronic infection or psychiatric illness/social situations that would limit compliance with study requirements. 6. Has evidence of mucositis/stomatitis at screening or baseline, or has history of severe (≥Grade 3) mucositis/stomatitis from prior therapy. 7. Has any condition that, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study. 8. Has received prior treatment with L-asparaginase. 9. Pregnant or breastfeeding. 10. Known hypersensitivity to anthracyclines, cytarabine, the excipients of L Annamycin for Injection or Cytarabine Injection, or contrast media that may be used for the protocol-specified GLS assessments. 11. Has received a total cumulative prior anthracycline dose of \> 300 mg/m2 (daunorubicin equivalent dose). 12. Has relapsed or refractory AML with a FLT3 mutation, unless resides in a country where gilteritinib is not available.

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Conditions

The condition(s) this trial relates to.

acute myeloblastic leukemia with maturation acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukaemia (AML)

How to take part

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

  1. The places running it

    28 sites in 9 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

  • AOU Careggi

    RECRUITING

    Florence, 50134, Italy

  • ARENSIA Exploratory Medicine, LLC

    RECRUITING

    Kyiv, 01135, Ukraine

  • ARENSIA research clinic at the Oncology Institute "Prof. Dr. Ion Chiricuţă"

    RECRUITING

    Cluj-Napoca, 400015, Romania

  • AUSL della Romagna - Santa Maria delle Croci - Ravenna

    RECRUITING

    Ravenna, 48121, Italy

  • Atlantic Health

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Augusta University - Georgia Cancer Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Bioresearch Partners

    RECRUITING

    Miami, Florida, 33155, United States

  • Caucasus Medical Center

    RECRUITING

    Tbilisi, 0186, Georgia

  • Fakultní nemocnice Hradec Králové

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart

    RECRUITING

    Roma, 00168, Italy

  • GEORGIA: LLC ARENSIA Exploratory Medicine

    RECRUITING

    Tbilisi, 0112, Georgia

  • Hospital MD Anderson Cancer Center Madrid

    RECRUITING

    Madrid, 28033, Spain

  • Hospital Universitario Central de Asturias (HUCA)

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario La Fe de Valencia

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Institut Català d'Oncología (ICO) - Hospital Germans Trias i Pujol

    RECRUITING

    Barcelona, Badalona, 08916, Spain

  • Instytut Hematologii i Transfuzjologii, Klinika Hematologii

    RECRUITING

    Warsaw, 02-776, Poland

  • LSMU Kauno klinikos

    RECRUITING

    Kaunas, LT-50161, Lithuania

  • Oddział Hematologii i Transplantacji Szpiku, Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 60-569, Poland

  • RCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia

    RECRUITING

    Bologna, 40138, Italy

  • Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku

    RECRUITING

    Olsztyn, 10-228, Poland

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama Birmingham

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19117, United States

  • University of Rhode Island

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Uniwersytecki Szpital Kliniczny Klinika Hematologii i Transplantologii (Szczecin)

    RECRUITING

    Szczecin, 71-252, Poland

  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddział Hematologii

    RECRUITING

    Torun, 87-100, Poland

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