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

Conditions

• Acute Myeloid Leukaemia (AML)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo in combination with Cytarabine Injection — DRUG
  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.
• Liposomal Annamycin Injection in combination with Cytarabine Injection — DRUG
  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.
• Liposomal Annamycin Injection in combination with Cytarabine Injection — DRUG
  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.
• Liposomal Annamycin for Injection in combination with Cytarabine Injection. — DRUG
  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).

Study Details

This pivotal phase 2/3, multi-center, adaptive design study of L-Annamycin for Injection in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML is divided into two parts, Part A and Part B.

Key Dates

Start date

Mar 12, 2025

Status verified

Apr 2026

Primary completion

Aug 31, 2029

Completion

Aug 31, 2030

Study Design

Enrollment

312 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Part A / Treatment Arm 1
  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
• Active Comparator: Part A / Treatment Arm 2
  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.
• Active Comparator: Part A / Treatment Arm 3
  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.
• Placebo Comparator: Part B / Treatment Arm 1
  Placebo (0.9% Sodium Chloride Injection) 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 1 of Part A).
• Active Comparator: Part B / Treatment Arm X
  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).

Primary Outcome Measure

Part A -Determination of Optimal Dosage Regimen [ Time Frame: From initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49 ]

Central Contacts

• Paul Waymack, MD, Sc.D
  +1 202-760-1378
  [email protected]
• Erikson Wasyl, MS
  860-395-9275
  [email protected]

Locations (6)

Find similar trials in Miami, FL

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