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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03045627

Enrollment

120

Registered

2017-02-07

Start date

2017-01-31

Completion date

2020-07-31

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, PEG-G-CSF

Brief 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.

Interventions

DRUGAraC

ARA-C subcutaneously in a 12-hour infusion on days 1 through 14

DRUGAclarubicin

Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8

DRUGPeg-G-CSF

PEG-G-CSF 6mg subcutaneously on days 0.

DRUGG-CSF

G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. age 60 years and older, with an upper age limit of 75 years; 2. diagnosis of AML other than APL 3. Adequate hepatic and renal function (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], bilirubin and creatinine \< 2.5 x upper normal limit).

Exclusion criteria

1. History of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin 2. Use of recreational drugs or history of drug addiction, within the prior 6 months 3. Known history of positive hepatitis B surface antigens or hepatitis C virus (HCV) antibodies 4. Patients with documented cases of human immunodeficiency virus (HIV)

Design outcomes

Primary

Measure	Time frame	Description
Complete remission (CR)	60 days from the enrollment	Bone marrow blasts not more than 5%, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count more than 1\10\^9/L, platelet count more than 100\10\^9/L,independence of red cell transfusions

Countries

China

Contacts

Primary ContactMing Hou, Docter

houming@medmail.com.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026