RecruitingAcute Myeloid Leukaemia (AML)
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
Eligible age
18–80 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
This pivotal phase 2/3, multi-center, adaptive design study of L-Annamycin for Injection in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML is divided into two parts, Part A and Part B.
Sponsor: Moleculin Biotech, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Alabama
Birmingham
Florida
Miami
Georgia
Augusta
Nebraska
Omaha
New Jersey
Morristown
Ohio
Cleveland
Pennsylvania
Philadelphia
Rhode Island
Providence
Source: ClinicalTrials.gov · NCT06788756 · last updated 2026-08-05