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New treatment option for Acute Myeloid Leukaemia (AML)
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
ClinicalTrials.gov ID: NCT06788756
What this study is testing
What is Liposomal Annamycin Injection in combination with Cytarabine Injection?
Liposomal Annamycin Injection in combination with Cytarabine Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukaemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet...
- Has refractory/relapsed AML after having received only one prior line of therapy\ . \ A prior line of therapy will be defined as the planned therapy...
- Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF).
- Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first assigned by chance dose of study drug or has recovered...
- Has received no investigational therapy within 4 weeks prior to the first assigned by chance dose of study drug.
You likely can't join if
- Has prior or current diagnosis of acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML
- Received prior mediastinal radiotherapy.
- Has central nervous system involvement.
- Has impaired cardiac function, including any of the following:
- Abnormal LVEF at screening [per American College of Cardiology, normal LVEF is 50 to 70%
- Valvular heart disease.
See the full eligibility criteria
- 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...
- Has refractory/relapsed AML after having received only one prior line of therapy\ . \ A prior line of therapy will be defined as the planned therapy consisting of one or more cycles of episodic treatment or a defined...
- Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF).
- Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first assigned by chance dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control...
- Has received no investigational therapy within 4 weeks prior to the first assigned by chance dose of study drug.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening.
- Has a life expectancy of greater than six weeks at screening.
- Has adequate laboratory results at screening including the following:
- Total bilirubin ≤2.0 times the upper limit of normal (ULN). For people with leukemic involvement or Gilbert Syndrome, total bilirubin must be ≤3.0 ULN.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \<3.5 times the ULN. For people with organ involvement, AST, ALT, and alkaline phosphatase must be ≤4.5 times the ULN.
- Creatinine clearance ≥60 mL/min (using Cockcroft-Gault equation).
- Can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol.
- 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 assigned by chance dose of study drug.
- 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 assigned by chance dose of study drug.
- 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 assigned by chance dose of...
- Has prior or current diagnosis of acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML
- Received prior mediastinal radiotherapy.
- Has central nervous system involvement.
- Has impaired cardiac function, including any of the following:
- Abnormal LVEF at screening [per American College of Cardiology, normal LVEF is 50 to 70%
- Valvular heart disease.
- Severe, uncontrolled hypertension.
- Uncontrolled cardiac arrhythmias.
- Recent (≤6 months prior to screening) myocardial infarction.
- Unstable angina.
- Symptomatic congestive heart failure.
- New York Heart Association (NYHA) classification of 3 or 4.
- QT interval/corrected QT (QTc) interval \>480 msec at screening.
- History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- . Use of concomitant medications with known risk of Torsades de Pointes (TdP) (i.e., drugs that prolong the QT interval and that are clearly associated with a known risk of TdP, even when taken as recommended; refer to...
- Has clinically relevant serious comorbid medical conditions including, but not limited to, active infection, chronic obstructive or chronic restrictive pulmonary disease, history of positive status for human...
- Has evidence of mucositis/stomatitis at screening or baseline, or has history of severe (≥Grade 3) mucositis/stomatitis from prior therapy.
- 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.
- Has received prior treatment with L-asparaginase.
- Pregnant or breastfeeding.
- 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.
- Has received a total cumulative prior anthracycline dose of \> 300 mg/m2 (daunorubicin equivalent dose).
- Has relapsed or refractory AML with a FLT3 mutation, unless resides in a country where gilteritinib is not available.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Augusta, Georgia, United States
- Omaha, Nebraska, United States
- Morristown, New Jersey, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Tbilisi, Georgia
- Bologna, Italy
- Florence, Italy
- Ravenna, Italy
- Roma, Italy
- Kaunas, Lithuania
- Olsztyn, Poland
- Poznan, Poland
- Szczecin, Poland
- Torun, Poland
- Warsaw, Poland
- Cluj-Napoca, Romania
- Barcelona, Badalona, Spain
- Oviedo, Principality of Asturias, Spain
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Augusta, Georgia, United States; Omaha, Nebraska, United States; Morristown, New Jersey, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.