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

Sponsor
Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03045627
Collaborator
(none)
120
1
2
42
2.9

Study Details

Study Description

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 ).

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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

    Active Comparator: 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.

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qilu hospital, Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Shandong University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ming Hou, Professor and Director, Shandong University
    ClinicalTrials.gov Identifier:
    NCT03045627
    Other Study ID Numbers:
    • AML- PEG-G-CSF
    First Posted:
    Feb 7, 2017
    Last Update Posted:
    Feb 7, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Ming Hou, Professor and Director, Shandong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 7, 2017