RecruitingPhase 2Phase 3NCT06788756

L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML

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

Sponsor

Moleculin Biotech, Inc.

Enrollment

312 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukaemia (AML)

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — L-Annamycin and cytarabine — as a second attempt at getting acute myeloid leukemia (AML) into remission. AML is a fast-moving blood cancer where the bone marrow makes too many abnormal blood cells. This treatment is for patients whose AML did not respond to, or came back after, their first round of treatment. **You may be eligible if...** - You are an adult with acute myeloid leukemia (AML) confirmed by current diagnostic standards - Your AML did not respond to (refractory) or came back (relapsed) after exactly one prior line of therapy - Your overall health and organ function meet the study's requirements **You may NOT be eligible if...** - You have had more than one prior line of treatment for AML - Your organ function is not adequate - You have other conditions that make you ineligible per the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPlacebo in combination with Cytarabine Injection

placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUGLiposomal Annamycin Injection in combination with Cytarabine Injection

190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUGLiposomal Annamycin Injection in combination with Cytarabine Injection

230 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUGLiposomal Annamycin for Injection in combination with Cytarabine Injection.

optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A).

Locations(25)

Bioresearch Partners

Miami, Florida, United States

Augusta University - Georgia Cancer Center

Augusta, Georgia, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Atlantic Health

Morristown, New Jersey, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

GEORGIA: LLC ARENSIA Exploratory Medicine

Tbilisi, Georgia

Caucasus Medical Center

Tbilisi, Georgia

RCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia

Bologna, Italy

AOU Careggi

Florence, Italy

AUSL della Romagna - Santa Maria delle Croci - Ravenna

Ravenna, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of the Sacred Heart

Roma, Italy

LSMU Kauno klinikos

Kaunas, Lithuania

Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku

Olsztyn, Poland

Oddział Hematologii i Transplantacji Szpiku, Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Uniwersytecki Szpital Kliniczny Klinika Hematologii i Transplantologii (Szczecin)

Szczecin, Poland

Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddział Hematologii

Torun, Poland

Instytut Hematologii i Transfuzjologii, Klinika Hematologii

Warsaw, Poland

ARENSIA research clinic at the Oncology Institute "Prof. Dr. Ion Chiricuţă"

Cluj-Napoca, Romania

Institut Català d'Oncología (ICO) - Hospital Germans Trias i Pujol

Barcelona, Badalona, Spain

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, Spain

Hospital MD Anderson Cancer Center Madrid

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario La Fe de Valencia

Valencia, Spain

ARENSIA Exploratory Medicine, LLC

Kyiv, Ukraine

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06788756

Related Trials

A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies

NCT071548235 locations

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

NCT071481802 locations

Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

NCT055346204 locations

Maintenance Venetoclax in AML Fit Patients

NCT072443672 locations

Feasibility and Safety of Home Blood Count Measurement and Transfusions in Patients With Acute Myeloid Leukemia

NCT070622501 location