RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-12

Study Completion:2030-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06788756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML. The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN's 2022 recommendations 2. Has refractory/relapsed AML after having received only one prior line of therapy\*. 3. Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF). 4. Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first randomized dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control white blood cell (WBC) count, supportive measures, and prophylaxes as required under the protocol will be allowed. Treatment of opportunistic or other infections with antibiotics, antifungals, and/or antiviral agents, including therapy for meningeal disease (i.e., intrathecal chemotherapy), per institutional standards of care will be allowed during this period, as long as the symptoms of infection have resolved by 1 week prior to the first dose of randomized study drug. 5. Has received no investigational therapy within 4 weeks prior to the first randomized dose of study drug. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening. 7. Has a life expectancy of greater than six weeks at screening. 8. Has adequate laboratory results at screening including the following: 1. Total bilirubin ≤2.0 times the upper limit of normal (ULN). For subjects with leukemic involvement or Gilbert Syndrome, total bilirubin must be ≤3.0 ULN. 2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \<3.5 times the ULN. For subjects with organ involvement, AST, ALT, and alkaline phosphatase must be ≤4.5 times the ULN. 3. Creatinine clearance ≥60 mL/min (using Cockcroft-Gault equation). 9. Can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol. 10. For women of childbearing potential (WCBP): Must have a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test within 72 hours prior to the first randomized dose of study drug. 11. For WCBP: Must agree to not donate ova and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug. 12. For males with partners who are WCBP: Must agree to not donate sperm and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.	1. Has prior or current diagnosis of acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML 2. Received prior mediastinal radiotherapy. 3. Has central nervous system involvement. 4. Has impaired cardiac function, including any of the following: 1. Abnormal LVEF at screening \[per American College of Cardiology, normal LVEF is 50 to 70% 2. Valvular heart disease. 3. Severe, uncontrolled hypertension. 4. Uncontrolled cardiac arrhythmias. 5. Recent (≤6 months prior to screening) myocardial infarction. 6. Unstable angina. 7. Symptomatic congestive heart failure. 8. New York Heart Association (NYHA) classification of 3 or 4. 9. QT interval/corrected QT (QTc) interval \>480 msec at screening. 10. History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). 11. Use of concomitant medications that significantly prolong the QT/QTc interval. 5. Has clinically relevant serious comorbid medical conditions including, but not limited to, active infection, chronic obstructive or chronic restrictive pulmonary disease, known positive status for human immunodeficiency virus (virus detected in serum) and/or active hepatitis B or C, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Has evidence of mucositis/stomatitis at screening or baseline, or has history of severe (≥Grade 3) mucositis/stomatitis from prior therapy. 7. Has any condition that, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study. 8. Has received prior treatment with L-asparaginase. 9. Pregnant or breastfeeding. 10. Known hypersensitivity to anthracyclines, cytarabine, the excipients of L Annamycin for Injection or Cytarabine Injection, or contrast media that may be used for the protocol-specified GLS assessments. 11. Has received a total cumulative prior anthracycline dose of \> 300 mg/m2 (daunorubicin equivalent dose). 12. Has relapsed or refractory AML with a FLT3 mutation, unless resides in a country where gilteritinib is not available.

Inclusion Criteria

Exclusion Criteria

1. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML. The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN's 2022 recommendations
2. Has refractory/relapsed AML after having received only one prior line of therapy\*.
3. Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF).
4. Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first randomized dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control white blood cell (WBC) count, supportive measures, and prophylaxes as required under the protocol will be allowed. Treatment of opportunistic or other infections with antibiotics, antifungals, and/or antiviral agents, including therapy for meningeal disease (i.e., intrathecal chemotherapy), per institutional standards of care will be allowed during this period, as long as the symptoms of infection have resolved by 1 week prior to the first dose of randomized study drug.
5. Has received no investigational therapy within 4 weeks prior to the first randomized dose of study drug.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening.
7. Has a life expectancy of greater than six weeks at screening.
8. Has adequate laboratory results at screening including the following:
1. Total bilirubin ≤2.0 times the upper limit of normal (ULN). For subjects with leukemic involvement or Gilbert Syndrome, total bilirubin must be ≤3.0 ULN.
2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \<3.5 times the ULN. For subjects with organ involvement, AST, ALT, and alkaline phosphatase must be ≤4.5 times the ULN.
3. Creatinine clearance ≥60 mL/min (using Cockcroft-Gault equation).
9. Can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol.
10. For women of childbearing potential (WCBP): Must have a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test within 72 hours prior to the first randomized dose of study drug.
11. For WCBP: Must agree to not donate ova and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.
12. For males with partners who are WCBP: Must agree to not donate sperm and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.

1. Has prior or current diagnosis of acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML
2. Received prior mediastinal radiotherapy.
3. Has central nervous system involvement.
4. Has impaired cardiac function, including any of the following:
1. Abnormal LVEF at screening \[per American College of Cardiology, normal LVEF is 50 to 70%
2. Valvular heart disease.
3. Severe, uncontrolled hypertension.
4. Uncontrolled cardiac arrhythmias.
5. Recent (≤6 months prior to screening) myocardial infarction.
6. Unstable angina.
7. Symptomatic congestive heart failure.
8. New York Heart Association (NYHA) classification of 3 or 4.
9. QT interval/corrected QT (QTc) interval \>480 msec at screening.
10. History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
11. Use of concomitant medications that significantly prolong the QT/QTc interval.
5. Has clinically relevant serious comorbid medical conditions including, but not limited to, active infection, chronic obstructive or chronic restrictive pulmonary disease, known positive status for human immunodeficiency virus (virus detected in serum) and/or active hepatitis B or C, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Has evidence of mucositis/stomatitis at screening or baseline, or has history of severe (≥Grade 3) mucositis/stomatitis from prior therapy.
7. Has any condition that, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study.
8. Has received prior treatment with L-asparaginase.
9. Pregnant or breastfeeding.
10. Known hypersensitivity to anthracyclines, cytarabine, the excipients of L Annamycin for Injection or Cytarabine Injection, or contrast media that may be used for the protocol-specified GLS assessments.
11. Has received a total cumulative prior anthracycline dose of \> 300 mg/m2 (daunorubicin equivalent dose).
12. Has relapsed or refractory AML with a FLT3 mutation, unless resides in a country where gilteritinib is not available.

Contacts and Locations

Study Contact

Paul Waymack, MD, Sc.D

CONTACT

+1 202-760-1378

pwaymack@moleculin.com

Erikson Wasyl, MS

CONTACT

860-395-9275

ewasyl@moleculin.com

Study Locations (Sites)

Bioresearch Partners

Miami, Florida, 33155

United States

Collaborators and Investigators

Sponsor: Moleculin Biotech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12

Study Completion Date2030-08

Study Record Updates

Study Start Date2025-03-12

Study Completion Date2030-08

Terms related to this study

Additional Relevant MeSH Terms

Acute Myeloid Leukaemia (AML)