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NCT06788756 · ClinicalTrials.gov registry record · Phase 2
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
A Phase 2 study of Acute Myeloid Leukaemia (AML), sponsored by Moleculin Biotech.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
- 17
- Study locations
NCT06788756: Recruiting Phase 2 study of Acute Myeloid Leukaemia (AML), sponsored by Moleculin Biotech.
NCT06788756 is a Phase 2 study of Acute Myeloid Leukaemia (AML) that is actively recruiting participants, run by Moleculin Biotech. The registered enrollment target is 312 participants, above the 206-participant average among 3 other Acute Myeloid Leukaemia (AML) trials with a reported enrollment target (51% higher). The trial reports 17 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06788756, a Phase 2 study of Acute Myeloid Leukaemia (AML), is actively recruiting participants, sponsored by Moleculin Biotech.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
1\. To identify the optimal dosage regimen of L Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle.
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 |
What NCT06788756 shows while recruiting
NCT06788756 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 206-participant average among 3 other Acute Myeloid Leukaemia (AML) trials with a reported enrollment target (51% higher).
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.
NCT06788756 lists 17 locations in 4 states (Other, Florida, Ohio).
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).
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).
Who is sponsoring clinical trial NCT06788756?
This trial is sponsored by Moleculin Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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