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Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients

NCT04920500 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-06-09

No results posted yet for this study

Summary

A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence pretrial of Daunorubicin Cytarabine liposome for Injection in older, naive patients with Acute Myeloid Leukemia (AML).

Conditions

Interventions

DRUG

Daunorubicin Cytarabine liposome for injection

Induction 1: \[100 U/m²\] i.v. d1,3,5 Induction 2: \[100 U/m²\] i.v. d1,3

DRUG

Vyxeos、Daunorubicin Cytarabine liposome for injection

Induction 1: \[100 U/m²\] i.v. Vyxeos（d1）,Daunorubicin Cytarabine liposome for injection（d3、d5） Induction 2: \[100 U/m²\] i.v. Daunorubicin Cytarabine liposome for injection（d1、d3 ）

Sponsors & Collaborators

  • CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04920500 on ClinicalTrials.gov