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

Testing a new treatment for adults with relapsed AML.

Recruiting
18-80 years
All
Phase 2/3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study looks at a new treatment for adults with acute myeloid leukemia (AML) that hasn't improved with first treatment or has returned. AML is a type of blood cancer. The study tests a medicine called **L-Annamycin** combined with **Cytarabine**, which is another medicine, to see if it helps patients go into remission again. Remission is when cancer signs decrease or disappear. The study has two parts. Part A tests different doses to find the best one, while Part B uses the best dose found from Part A.

  • The study is expected to involve 297 patients in total, with 75 to 90 in Part A and 222 in Part B.
  • Participants will be randomly assigned to different treatment groups, and each treatment cycle lasts about 5 days.
  • To join, participants must be between 18 and 80 years old and meet certain health criteria.

Eligible participants must not have certain health issues like heart problems or other serious conditions that could affect participation. The study aims to find a better way to treat patients whose AML hasn't responded to previous treatment.

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Study details
    Acute Myeloid Leukaemia (AML)

NCT06788756

Moleculin Biotech, Inc.

25 April 2026

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