NCT06788756Phase 2, phase 3Recruiting

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

Study sponsor: Moleculin Biotech, Inc. · MBRX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2029-08Estimated

Enrollment · participants312Estimated

Source updated2026-08-05Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Acute Myeloid Leukaemia (AML)

Treatments or interventions studied

Placebo in combination with Cytarabine InjectionDrug
Liposomal Annamycin Injection in combination with Cytarabine InjectionDrug
Liposomal Annamycin Injection in combination with Cytarabine InjectionDrug
Liposomal Annamycin for Injection in combination with Cytarabine Injection.Drug

Primary outcomes · main study measures

Read the study measures

measure: Part A -Determination of Optimal Dosage Regimen; description: 1\. To identify the optimal dosage regimen of L Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle.; timeFrame: From initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49; measure: Part B - Expansion at Optimal Dosage Regimen; description: To confirm the superior efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of CR after one treatment cycle; timeFrame: From initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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