NCT06788756 - L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML | Biotech Hunter

Enrollment

312

Participants

Timeline

Start Date

March 12, 2025

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2030

Conditions

Acute Myeloid Leukaemia (AML)

Interventions

DRUG

Placebo in combination with Cytarabine Injection

placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUG

Liposomal Annamycin Injection in combination with Cytarabine Injection

190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUG

Liposomal Annamycin Injection in combination with Cytarabine Injection

230 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

DRUG

Liposomal Annamycin for Injection in combination with Cytarabine Injection.

optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A).

Trial Locations (13)

28033

ACTIVE_NOT_RECRUITING

Hospital MD Anderson Cancer Center Madrid, Madrid

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

33011

RECRUITING

Hospital Universitario Central de Asturias (HUCA), Oviedo

33155

RECRUITING

Bioresearch Partners, Miami

40138

RECRUITING

RCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia, Bologna

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

46026

RECRUITING

Hospital Universitario La Fe de Valencia, Valencia

400015

RECRUITING

"ARENSIA research clinic at the Oncology Institute Prof. Dr. Ion Chiricuţă", Cluj-Napoca

0112

RECRUITING

GEORGIA: LLC ARENSIA Exploratory Medicine, Tbilisi

0186

RECRUITING

Caucasus Medical Center, Tbilisi

10-228

RECRUITING

Szpital Kliniczny MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku, Olsztyn

60-569

ACTIVE_NOT_RECRUITING

Oddział Hematologii i Transplantacji Szpiku, Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

01135

RECRUITING

ARENSIA Exploratory Medicine, LLC, Kyiv