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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

NCT06788756 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Acute Myeloid Leukaemia (AML)

Interventions

DRUG

Placebo in combination with Cytarabine Injection

placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUG

Liposomal Annamycin Injection in combination with Cytarabine Injection

190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUG

Liposomal Annamycin Injection in combination with Cytarabine Injection

230 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUG

Liposomal Annamycin for Injection in combination with Cytarabine Injection.

optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2029-08-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Italy
  • Lithuania
  • Poland
  • Romania
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788756 on ClinicalTrials.gov