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

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.

Trial Details

NCT ID
NCT06788756
Phase
PHASE2 / PHASE3
Sponsor
Moleculin Biotech, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Placebo in combination with Cytarabine Injection
  • Liposomal Annamycin Injection in combination with Cytarabine Injection
  • Liposomal Annamycin for Injection in combination with Cytarabine Injection.
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Miami, Florida, United States|25.77427,-80.19366
  • Augusta, Georgia, United States|33.47097,-81.97484
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • Morristown, New Jersey, United States|40.79677,-74.48154

Key Eligibility Criteria

  • Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (E…
  • Has refractory/relapsed AML after having received only one prior line of therapy\*.
  • \*A prior line of therapy will be defined as the planned therapy consisting of one or more cycles of episodic treatment or a defined period of cont…
  • Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF).

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →