Phase 23 Study of L-Annamycin with Cytarabine Versus Placebo in Adults Aged 18 to 80 with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are studying L-Annamycin for Injection combined with Cytarabine Injection as a second line treatment for inducing remission in adults with refractory or relapsed acute myeloid leukemia AML. This important phase 23, multi-center trial is divided into two parts Part A focuses on finding the best dosage of L-Annamycin, while Part B expands on the optimal dosage to further evaluate its effects. The study aims to compare the combination therapy to a placebo with Cytarabine Injection in adult patients who have received only one prior line of therapy. In Part A, participants are randomly assigned to receive either a placebo or one of two doses of L-Annamycin 190 mgm2day or 230 mgm2day for three consecutive days, combined with Cytarabine Injection at 2.0 gm2day for five consecutive days. Both drugs are given through intravenous infusions, with L-Annamycin over 2 hours and Cytarabine over 4 hours, administered on the same days with a recommended 15-minute gap between infusions. Two interim analyses will assess safety, efficacy, and pharmacokinetics to decide which dosage regimens continue or are dropped. Part B will enroll additional participants to further study the optimal dosage determined in Part A, continuing the same treatment schedule. Participants will undergo screening and baseline assessments before enrollment. During the study, they will have bone marrow assessments up to 49 days after starting treatment to evaluate remission. Safety and tolerability will be monitored, with overall survival tracked up to two years after the first dose. The study includes detailed laboratory tests, performance status evaluations, and monitoring for side effects. Participants must comply with birth control requirements if applicable and will be followed closely throughout the trial until completion around August 2030.

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