A Pivotal Phase 2/3, 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

Summary

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.

Description

Eligibility

Age range

18–80 years

Sex

All

Healthy volunteers

No

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).

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