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L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
NCT06788756 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo in combination with Cytarabine Injection
- DRUG Liposomal Annamycin Injection in combination with Cytarabine Injection
- DRUG Liposomal Annamycin for Injection in combination with Cytarabine Injection.
Study Locations (17)
Other
- GEORGIA: LLC ARENSIA Exploratory Medicine — Tbilisi
- Caucasus Medical Center — Tbilisi
- RCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia — Bologna
- LSMU Kauno klinikos — Kaunas
- Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku — Olsztyn
- Oddział Hematologii i Transplantacji Szpiku, Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
- Uniwersytecki Szpital Kliniczny Klinika Hematologii i Transplantologii (Szczecin) — Szczecin
- Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddział Hematologii — Torun
- Instytut Hematologii i Transfuzjologii, Klinika Hematologii — Warsaw
- ARENSIA research clinic at the Oncology Institute "Prof. Dr. Ion Chiricuţă" — Cluj-Napoca
- Hospital MD Anderson Cancer Center Madrid — Madrid
- Hospital Universitario Ramón y Cajal — Madrid
- Hospital Universitario La Fe de Valencia — Valencia
- ARENSIA Exploratory Medicine, LLC — Kyiv
Florida
- Bioresearch Partners — Miami
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
Principality of Asturias
- Hospital Universitario Central de Asturias (HUCA) — Oviedo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2025-03-12 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06788756
The ClinicalTrials.gov registry entry for NCT06788756 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Moleculin Biotech, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Myeloid Leukaemia (AML) appearing as the primary indexed condition, and to 3 interventions — of which Placebo in combination with Cytarabine Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06788756 reports 17 study locations spanning 4 distinct geographic areas — top geographies include Other, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06788756 about?
NCT06788756 is a clinical study titled "L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML". 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.
What is the current status of trial NCT06788756?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2025-03-12. Estimated completion is 2030-08.
What conditions does trial NCT06788756 study?
This clinical trial studies the following conditions: Acute Myeloid Leukaemia (AML). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06788756?
The interventions under investigation include: Placebo in combination with Cytarabine Injection (DRUG), Liposomal Annamycin Injection in combination with Cytarabine Injection (DRUG), Liposomal Annamycin for Injection in combination with Cytarabine Injection. (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06788756?
This trial is sponsored by Moleculin Biotech, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06788756 being conducted?
This trial has 17 study locations across Florida, Ohio, Principality of Asturias. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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