Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)

NCT01145846 | Unknown Phase 3 DMC

• 1 other identifier: C-022
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this non-inferiority study is to compare the effectiveness of two induction chemotherapy regimens (cytarabine plus idarubicin \[AI\] versus cytarabine plus high-dose daunorubicin \[AD\]) in AML. The effectiveness will be evaluated in terms of complete remission (CR) rate.

Conditions

Acute Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete remission rate

  A complete remission will be defined as blasts of 5% or less in a normocellular bone marrow with neutrophils of 1,000/mcL or more and platelets of 100,000/mcL or more in the peripheral blood, the disappearance of all blasts in the peripheral blood, and no evidence of extramedullary leukemic cell infiltration

  five years

Secondary Outcomes (1)

• Duration of CR, relapse-free survival(RFS),event-free survival(EFS),Overall survival(OS)

  Five years

Study Arms (1)

Arm I (AI regimen)

EXPERIMENTAL

Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Idarubicin 12 mg/m2/day iv daily for 3 days (D 1-3)

Drug: Cytarabine plus Daunorubicin [Arm II (AD regimen)]

Interventions

Cytarabine plus Daunorubicin [Arm II (AD regimen)] DRUG

Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Daunorubicin 90 mg/m2/day iv daily for 3 days (D 1-3)

Also known as: Cytarabine /Idarubicin

Arm I (AI regimen)

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with previously-untreated acute myeloid leukemia (20% or more of blasts in bone marrow and/or blood; M6 subtype may have less than 20% of blasts.). Therapy-related leukemia or leukemia after myelodysplastic syndrome will be included.
• years old or older, but 65 years or younger
• Adequate performance status (Karnofsky score of 50 or more)
• Adequate hepatic and renal function (AST, ALT, bilirubin and creatinine \< 2.5 x upper normal limit). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.
• Adequate cardiac function (left ventricular ejection fraction of 45% or more on heart scan or echocardiogram)
• Signed and dated informed consent must be obtained

You may not qualify if:

• Patients with acute promyelocytic leukemia or bcr-abl gene rearrangement
• Patients with CNS leukemia
• Patients with primary granulocytic sarcoma without bone marrow involvement
• Prior chemotherapy for leukemia or anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
• Presence of significant active infection
• Presence of uncontrolled bleeding
• Significant cardiovascular disease including myocardial infarction within previous 6 months
• Any coexisting major illness or organ failure
• Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
• Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
• Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

Sponsors & Collaborators

• Cooperative Study Group A for Hematology: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

RECRUITING

Related Links

• A prospective randomized comparison of idarubicin and high-dose daunorubicin in combination with cytarabine in the induction chemotherapy for acute myeloid leukemia

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Daunorubicin; Idarubicin

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

Study Officials

• Je Hwan Lee, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Je-Hwan Lee, professor

CONTACT

82-2-3010-3218; jhlee3@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: June 17, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2014
• Last Updated: June 17, 2010

Record last verified: 2010-06

Locations

KR (1)