L-Annamycin + Cytarabine in Relapsed/Refractory AML

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Will this trial meet its primary endpoint?

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DetailsModel PositionsModel SnapshotsOracle
Primary Completion
8/1/29
Study Completion
8/1/30
Sponsor
Moleculin Biotech, Inc.
$MBRX
Type
Phase 2/Phase 3
Trial Status
Recruiting
Trial Size
312
Volume
$1.1K
NCT
NCT06788756
Trial Description
Pivotal adaptive Phase 2/Phase 3 randomized, double-blind, placebo-controlled trial of L-Annamycin plus cytarabine in adults with refractory/relapsed AML after one prior line of therapy. Part A selects between two L-Annamycin dose levels using complete remission after one cycle, then Part B expands the chosen regimen against placebo plus cytarabine. The study is recruiting with estimated enrollment of 312 across multiple countries.