Actively Recruiting
A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L-Annamycin for Injection in Combination With Cytarabine Injection Versus Placebo in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed Acute Myeloid Leukemia
Led by Moleculin Biotech, Inc. · Updated on 2026-04-29
312
Participants Needed
25
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating L-Annamycin for Injection combined with Cytarabine Injection as a second line treatment for adult patients with refractory or relapsed acute myeloid leukemia (AML). This pivotal phase 2/3, multi-center, adaptive study aims to find the best dose of L-Annamycin when used with Cytarabine and assess its effectiveness and safety compared to a placebo with Cytarabine. The study focuses on patients who have received only one prior line of therapy and have not responded or have relapsed. The study is divided into two parts. Part A compares two doses of L-Annamycin (190 mg/m2/day and 230 mg/m2/day) given for three consecutive days alongside Cytarabine given for five consecutive days against a placebo with Cytarabine. Treatments are administered through intravenous infusions over several hours, with careful timing between drugs. Part A includes two interim analyses to determine the optimal dose and whether the study should continue. Part B then expands enrollment, testing the chosen dose of L-Annamycin with Cytarabine against placebo with Cytarabine in more participants. Participants will undergo screening and baseline assessments before enrollment and randomization to treatment groups. Researchers will monitor treatment response with bone marrow assessments up to Day 49 after the first treatment cycle. Safety, tolerability, pharmacokinetics, and overall survival up to two years are also measured. The study includes regular safety monitoring, with participation lasting through treatment cycles and follow-up assessments. The study is expected to end in August 2030.
CONDITIONS
Brief 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...
- Has a confirmed diagnosis of acute myeloid leukemia (AML) according to 2022 guidelines
- Has refractory or relapsed AML after only one prior line of therapy
- Is between 18 and 80 years old at the time of consent
- Has not received chemotherapy, radiation, or major surgery within 2 weeks prior to starting the study drug or has recovered from those treatments
- Has not received investigational therapy within 4 weeks prior to starting the study drug
- Has an ECOG performance status of 0 to 2
- Has a life expectancy greater than six weeks
- Has adequate liver and kidney function as defined by specific lab test limits
- Can understand, sign consent, and comply with study requirements
- For women of childbearing potential, has a negative pregnancy test and agrees to use effective birth control
- For men with partners who are women of childbearing potential, agrees to use effective birth control
You will not qualify if you...
- Has acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML
- Has received prior mediastinal radiotherapy
- Has involvement of the central nervous system
- Has impaired heart function including abnormal ejection fraction, valve disease, severe hypertension, arrhythmias, recent heart attack, unstable angina, heart failure, or prolonged QT interval
- Uses medications that increase the risk of certain heart rhythm problems unless safely monitored
- Has serious medical conditions such as active infections, chronic lung disease, HIV, hepatitis with symptoms, or psychiatric/social issues limiting compliance
- Has mucositis or stomatitis currently or severe history from prior therapy
- Has conditions that increase risk according to the investigator
- Has received prior treatment with L-asparaginase
- Is pregnant or breastfeeding
- Has known allergies to anthracyclines, cytarabine, study drug components, or contrast media used in assessments
- Has had a total anthracycline dose over 300 mg/m2
- Has relapsed or refractory AML with a FLT3 mutation unless in a country without access to gilteritinib
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive either L-Annamycin for Injection at one of two dose levels or placebo, each combined with Cytarabine Injection, administered as intravenous infusions over consecutive days.
Up to 5 consecutive days of in-person visits for infusions
Duration - Up to 44 days after treatment
Participants are monitored after the treatment cycle with bone marrow assessments and additional safety and efficacy evaluations.
1 to 2 visits for post-treatment bone marrow assessments and follow-up
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
E
Erikson Wasyl, MS
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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