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

NCT ID: NCT03045627

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-07-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Ara-C, Aclarubicin Combined PEG-G-CSF

ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, PEG-G-CSF 6mg subcutaneously on days 0. One course includes 28 days.

Group Type: ACTIVE_COMPARATOR

AraC

Intervention Type: DRUG

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

Aclarubicin

Intervention Type: DRUG

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

Peg-G-CSF

Intervention Type: DRUG

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

Active comparator

Ara-C, Aclarubicin Combined G-CSF

ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14. G-CSF was postponed or interrupted in case of white blood cell (WBC) count greater than 20 × 109/L .

One course includes 28 days.

Group Type: ACTIVE_COMPARATOR

AraC

Intervention Type: DRUG

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

Aclarubicin

Intervention Type: DRUG

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

G-CSF

Intervention Type: DRUG

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

Interventions

AraC

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

Intervention Type: DRUG

Aclarubicin

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

Intervention Type: DRUG

Peg-G-CSF

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

Intervention Type: DRUG

G-CSF

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

Intervention Type: DRUG

Other Intervention Names

cytarabine; Aclarubicin A

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu hospital, Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Hou, Docter

Role: CONTACT

houming@medmail.com.cn

Facility Contacts

Ming Hou

Role: primary

houming@medmail.com.cn

Other Identifiers

AML- PEG-G-CSF

Identifier Type: -

Identifier Source: org_study_id