L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
← catalyst calendarNCT06788756 · readout ≤ 1,108 d
Sponsored by Moleculin Biotech, Inc. (industry) · MBRX — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
312estimated
Sites
28
Countries
Czechia, Georgia, Italy +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-12 | actual | When the study began enrolling |
| Primary completion | Aug 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acute Myeloid Leukaemia (AML)
Interventions
- Drug: Placebo in combination with Cytarabine Injection
- Drug: Liposomal Annamycin Injection in combination with Cytarabine Injection
- Drug: Liposomal Annamycin Injection in combination with Cytarabine Injection
- Drug: Liposomal Annamycin for Injection in combination with Cytarabine Injection.
Primary outcomes
what the primary-completion date above is the date OFPart A -Determination of Optimal Dosage Regimen
measured From initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49
Part B - Expansion at Optimal Dosage Regimen
measured From initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49
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