Actively Recruiting
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
Led by Moleculin Biotech, Inc. · Updated on 2026-04-29
312
Participants Needed
25
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of AML according to 2022 classification and guidelines
- Refractory or relapsed AML after only one prior line of therapy
- Age between 18 and 80 years inclusive at informed consent
- No chemotherapy, radiation, or major surgery within 2 weeks before first study drug dose or recovered from side effects
- No investigational therapy within 4 weeks before first study drug dose
- ECOG performance status of 0 to 2 at screening
- Life expectancy greater than six weeks at screening
- Adequate lab results: bilirubin, liver enzymes, and creatinine clearance within specified limits
- Ability to understand and sign informed consent and comply with study requirements
- For women of childbearing potential: negative pregnancy test within 72 hours before first dose
- For women of childbearing potential: agree to use effective birth control from consent through 6 months after last dose
- For males with partners of childbearing potential: agree to use effective birth control from consent through 6 months after last dose
You will not qualify if you...
- Prior or current diagnosis of acute promyelocytic leukemia or myelodysplastic syndrome/AML
- Prior mediastinal radiotherapy
- Central nervous system involvement
- Impaired cardiac function including abnormal LVEF, valvular disease, severe hypertension, arrhythmias, recent myocardial infarction, unstable angina, symptomatic heart failure, NYHA class 3 or 4, QTc >480 msec, or risk factors for torsade des pointes
- Use of medications with known risk of torsades de pointes unless deemed safe by investigator
- Serious medical conditions like active infection, lung disease, HIV, hepatitis B or C with symptoms, or psychiatric/social issues limiting compliance
- Presence or history of severe mucositis/stomatitis
- Any condition posing unacceptable risk as judged by investigator
- Prior treatment with L-asparaginase
- Pregnant or breastfeeding
- Known allergy to anthracyclines, cytarabine, excipients of study drugs, or contrast media used in assessments
- Prior cumulative anthracycline dose over 300 mg/m2 (daunorubicin equivalent)
- Refractory or relapsed AML with FLT3 mutation unless gilteritinib is unavailable in country
AI-Screening
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Trial Site Locations
Total: 25 locations
1
Bioresearch Partners
Miami, Florida, United States, 33155
Actively Recruiting
2
Augusta University - Georgia Cancer Center
Augusta, Georgia, United States, 30912
Actively Recruiting
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
4
Atlantic Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
5
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
6
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19117
Actively Recruiting
7
GEORGIA: LLC ARENSIA Exploratory Medicine
Tbilisi, Georgia, 0112
Actively Recruiting
8
Caucasus Medical Center
Tbilisi, Georgia, 0186
Actively Recruiting
9
RCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia
Bologna, Italy, 40138
Actively Recruiting
10
AOU Careggi
Florence, Italy, 50134
Actively Recruiting
11
AUSL della Romagna - Santa Maria delle Croci - Ravenna
Ravenna, Italy, 48121
Actively Recruiting
12
Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart
Roma, Italy, 00168
Actively Recruiting
13
LSMU Kauno klinikos
Kaunas, Lithuania, LT-50161
Actively Recruiting
14
Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku
Olsztyn, Poland, 10-228
Actively Recruiting
15
Oddział Hematologii i Transplantacji Szpiku, Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland, 60-569
Actively Recruiting
16
Uniwersytecki Szpital Kliniczny Klinika Hematologii i Transplantologii (Szczecin)
Szczecin, Poland, 71-252
Actively Recruiting
17
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddział Hematologii
Torun, Poland, 87-100
Actively Recruiting
18
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Warsaw, Poland, 02-776
Actively Recruiting
19
ARENSIA research clinic at the Oncology Institute "Prof. Dr. Ion Chiricuţă"
Cluj-Napoca, Romania, 400015
Actively Recruiting
20
Institut Català d'Oncología (ICO) - Hospital Germans Trias i Pujol
Barcelona, Badalona, Spain, 08916
Actively Recruiting
21
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
22
Hospital MD Anderson Cancer Center Madrid
Madrid, Spain, 28033
Actively Recruiting
23
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
24
Hospital Universitario La Fe de Valencia
Valencia, Spain, 46026
Actively Recruiting
25
ARENSIA Exploratory Medicine, LLC
Kyiv, Ukraine, 01135
Actively Recruiting
Research Team
P
Paul Waymack, MD, Sc.D
CONTACT
E
Erikson Wasyl, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
5
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