Study on L-Annamycin and Cytarabine for Treating Difficult or Returning Acute Myeloid Leukemia (AML)
Sponsor: Moleculin Biotech, Inc.
ClinicalTrials ID:NCT06788756
This clinical trial is testing a new combination of drugs, L-Annamycin and Cytarabine, to see if they can help patients with acute myeloid leukemia (AML) that has not responded to previous treatment or has returned. The study is divided into two parts to find the best dosage and evaluate its effectiveness.
Patient Parameters
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Program Overview
The study aims to find out if a combination of L-Annamycin and Cytarabine can help patients with acute myeloid leukemia (AML) that has not responded to initial treatment or has come back. It is divided into two parts: Part A will determine the best dosage, and Part B will test the effectiveness of this dosage in a larger group of patients.
Description
This study is testing a new treatment for adults with acute myeloid leukemia (AML) that hasn't responded to previous treatment or has returned. The treatment combines two drugs, L-Annamycin and Cytarabine, and the study is divided into two parts.
In Part A, researchers will test different doses of L-Annamycin combined with Cytarabine to find the best dosage. Participants will be randomly assigned to one of three groups: one group will receive a placebo with Cytarabine, and the other two groups will receive different doses of L-Annamycin with Cytarabine. The goal is to see which dosage works best and is safest.
In Part B, the study will continue with the best dosage found in Part A. More participants will be enrolled to confirm the effectiveness and safety of this treatment combination.
Participants will receive the treatment through an IV infusion over several days and will be closely monitored for their response and any side effects. The study aims to provide a new option for patients with difficult-to-treat AML.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with acute myeloid leukemia (AML) according to specific medical guidelines.
- AML has not responded to one previous treatment or has returned after treatment.
- Aged between 18 and 80 years old.
- No recent chemotherapy, radiation, or major surgery within two weeks before starting the study treatment.
- No investigational therapy within four weeks before starting the study treatment.
- Good overall health with an ECOG performance status of 0 to 2.
- Life expectancy of more than six weeks.
- Adequate liver and kidney function based on specific blood tests.
- Able to understand and sign a consent form.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for six months after.
- Men with partners who are women of childbearing potential must agree to use effective birth control during the study and for six months after.
Exclusion Criteria
- Diagnosis of acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML.
- Previous mediastinal radiotherapy.
- Cancer has spread to the central nervous system.
- Heart problems, such as abnormal heart function, severe high blood pressure, or recent heart attack.
- Serious medical conditions, such as active infections or lung diseases.
- Severe mouth sores from previous treatments.
- Any condition that poses a high risk to the participant's health.
- Previous treatment with L-asparaginase.
- Pregnant or breastfeeding.
- Allergies to the study drugs or their components.
- High previous doses of anthracyclines.
- AML with a specific FLT3 mutation, unless in a country where gilteritinib is not available.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Bioresearch Partners | 33155 | Miami | Florida |
| University Hospitals Cleveland Medical Center | 44106 | Cleveland | Ohio |
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