A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L Annamycin for Injection in Combination with Cytarabine Injection Versus Placebo in Combination with Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects with Refractory/Relapsed Acute Myeloid Leukemia

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518359-47-00

Acronym

MB-108

Enrollment

177

Registered

2025-04-30

Start date

2025-06-17

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Brief summary

Rate of CR after one treatment cycle (35 days ± 14 days after initiation of randomized treatment)

Detailed description

DoR, OS, Rate of subsequent transplantation (i.e., alloHSCT/autoHSCT) for subjects who achieve CR or CRh at 35 days ± 14 days after initiation of randomized treatment (CR + CRh), Pharmacokinetics of annamycin (Part A and Part B), annamycinol (Part A and Part B), and cytarabine (Part A)., Safety, Tolerability

Interventions

DRUGCYTARABINE

DRUG0.9% Sodium Chloride Injection

DRUGUSP/Ph. Eur./BP/JP

DRUGLiposomal Annamycin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of CR after one treatment cycle (35 days ± 14 days after initiation of randomized treatment)	—

Secondary

Measure	Time frame
DoR, OS, Rate of subsequent transplantation (i.e., alloHSCT/autoHSCT) for subjects who achieve CR or CRh at 35 days ± 14 days after initiation of randomized treatment (CR + CRh), Pharmacokinetics of annamycin (Part A and Part B), annamycinol (Part A and Part B), and cytarabine (Part A)., Safety, Tolerability	—

Countries

Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026