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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03045627
• Other study ID #: AML- PEG-G-CSF
• Status: Recruiting
• Phase: Phase 2
• First received: January 16, 2017
• Last updated: February 3, 2017
• Start date: January 2017
• Est. completion date: July 2020

Study information

• Verified date: January 2017
• Source: Shandong University
• Contact: Ming Hou, Docter
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
China	Qilu hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission (CR)	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	60 days from the enrollment