A Pivotal Phase II/III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L-Annamycin for Injection in Combination with Cytarabine Injection Versus Placebo in Combination with Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects with Refractory/Relapsed Acute Myeloid Leukemia
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: II/III
Principal Investigator: Ellithi, Moataz
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06788756?term=NCT06788756&rank=1#participation-criteria
Summary
Part A (Determination of Optimal Dosage Regimen)
-Primary Objective: The primary objective of Part A of this study is 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 AML as measured by rate of CR
after one treatment cycle.
-Secondary Objective: The secondary objective of Part A of this study is to compare the efficacy of two dose levels of
L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day)
versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult
subjects with refractory/relapsed AML as measured by OS.
-Exploratory Objectives:
There are six exploratory objectives that did not fit within the character limit.
Part B (Expansion at Optimal Dosage Regimen)
-Primary Objective: The primary objective of Part B of this study is 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.
-Secondary Objective: The secondary objective of Part B of this study is to confirm the 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 OS.
-Exploratory Objectives:
There are six exploratory objectives that did not fit within the character limit.