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

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ClinicalTrials.gov Identifier: NCT03045627
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

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
Acute Myeloid Leukemia Drug: AraC Drug: Aclarubicin Drug: Peg-G-CSF Drug: G-CSF 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2020


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 Name: cytarabine

Drug: Aclarubicin
Aclarubicin(Acla) 5~7mg/m2/d,intravenously on days 1 through 8
Other Name: 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 Name: cytarabine

Drug: Aclarubicin
Aclarubicin(Acla) 5~7mg/m2/d,intravenously on days 1 through 8
Other Name: Aclarubicin A

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




Primary Outcome Measures :
  1. Complete remission (CR) [ Time Frame: 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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045627


Contacts
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Contact: Ming Hou, Docter houming@medmail.com.cn

Locations
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China, Shandong
Qilu hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou       houming@medmail.com.cn   
Principal Investigator: Ming Hou         
Sponsors and Collaborators
Shandong University

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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT03045627     History of Changes
Other Study ID Numbers: AML- PEG-G-CSF
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ming Hou, Shandong University:
Acute Myeloid Leukemia
PEG-G-CSF
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Aclarubicin
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors