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

NCT03045627 | Unknown Phase 2 DMC

• 1 other identifier: AML- PEG-G-CSF
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 ).

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; PEG-G-CSF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental

ACTIVE COMPARATOR

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; Drug: Aclarubicin; Drug: Peg-G-CSF

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; Drug: Aclarubicin; Drug: G-CSF

Interventions

AraC DRUG

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

Also known as: cytarabine

Active comparator; Experimental

Aclarubicin DRUG

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

Also known as: Aclarubicin A

Active comparator; Experimental

Peg-G-CSF DRUG

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

Experimental

G-CSF DRUG

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

Active comparator

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Aclarubicin; pegylated granulocyte colony-stimulating factor, human; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Ming Hou, Docter

CONTACT

houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: February 7, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2020
• Last Updated: February 7, 2017

Record last verified: 2017-01

Locations

CN (1)