NCT03045627

Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients

A Multi-center Randomized Open-label Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of Acute Myeloid Leukemia Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen ) has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires daily administration because of its short half-life． Pegylated granulocyte colony-stimulating factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C, aclarubicin and G-CSF (CAG ).

Detailed description

The Investigators are undertaking a parallel, multicentre, randomised open-label trial of newly diagnosed AML (not APL) patients in China. Participants are randomised selected to receive the regimen of Ara-C, aclarubicin and PEG-G-CSF , or the regimen of Ara-C, aclarubicin and G-CSF (CAG ).Platelet count, bleeding and other symptoms are evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	AraC	ARA-C subcutaneously in a 12-hour infusion on days 1 through 14
DRUG	Aclarubicin	Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8
DRUG	Peg-G-CSF	PEG-G-CSF 6mg subcutaneously on days 0.
DRUG	G-CSF	G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-01-01
• Completion: 2020-07-01
• First posted: 2017-02-07
• Last updated: 2017-02-07

Locations

1 site across 1 country: China