L-Annamycin and Cytarabine for Relapsed/Refractory AML
This study is testing a new combination treatment for adults with acute myeloid leukemia (AML) that has come back or not responded to previous treatment. The treatment involves L-Annamycin for Injection along with Cytarabine Injection. Researchers want to find the best dose of L-Annamycin to use with Cytarabine. You could be eligible if you are between 18 and 80 years old and have a confirmed diagnosis of AML that has returned or not responded after one prior treatment. The main goal is to see how well the treatment helps patients achieve remission. The study plans to enroll 312 participants, but the current recruitment status is unclear.
- Study design
- This is a Phase 2/3, multi-center study with an adaptive design. It is randomized, double-blind, and placebo-controlled, comparing two doses of L-Annamycin plus Cytarabine against a placebo plus Cytarabine.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured from the start of treatment until the first bone marrow assessment, up to Day 49.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
At a glance
Conditions
Where it's being run
28 sites across 17 statesWho to contact
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What this trial measures
- Part A -Determination of Optimal Dosage RegimenFrom initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49
1\. To identify the optimal dosage regimen of L Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle.
- Part B - Expansion at Optimal Dosage RegimenFrom initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49
To confirm the superior efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of CR after one treatment cycle