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A Remission Induction Therapy and Risk-oriented Postremission Strategy for Adult Acute Myelogenous Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT00495287
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
DR RENATO BASSAN, Northern Italy Leukemia Group

Brief Summary:

The study was set up to assess:

  1. Standard-dose versus high-dose remission induction therapy. A standard ICE chemotherapy vs sequential high-dose cytarabine, with appropriate supportive/prophylactic measures, followed by morphological, cytogenetic and molecular monitoring of remission.
  2. A risk-oriented postremission therapy: HR patients will be electively submitted to allogeneic stem cell transplantation (allo-SCT), whenever possible (related/unrelated donor/cord blood; ablative/non-ablative conditioning according to national and local protocols and guidelines). Provided sufficient blood stem cells were previously collected (>2x10e6/kg Cluster of Differentiation 34 cells), SR patients and HR patients excluded from allo-SCT and aged 65 years or less will be randomized to: myeloablative autologous blood stem cell transplantation vs non-myeloablative, multicycle, autologous blood stem cell-supported high-dose cytarabine-based therapy.

    • HR/SR patients unable to be randomized because of inadequate blood stem cell yield will receive intermediate-dose consolidation; patients aged >65 years will be treated with age-adapted therapy.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: cytosine arabinoside Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 573 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial in AML Comparing Standard-dose vs High-dose Remission Induction and, Within a Risk-oriented Postremission Strategy, Autologous Blood Stem Cell Transplantation vs Blood Stem Cell-supported Multicycle High-dose Program
Study Start Date : November 2006
Primary Completion Date : July 2015
Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: A
Remission induction arm A is with conventional chemotherapy cycle ("ICE": idarubicin, standard-dose cytarabine, etoposide)
Drug: cytosine arabinoside

Arm A: use of standard-dose cytosine arabinoside (100 mg/m2/bd iv. on days 1-7) in association with idarubicin and etoposide.

Arm B: use of high-dose cytosine arabinoside (1000-2000 mg/m2/bd according to age +/-65 years iv. on days 1-2 and 8-9) in association with idarubicin.

Other Names:
  • Aracytin
  • Cytarabine
  • Cytosar
Experimental: B
Remission induction therapy with high-dose cytarabine sequential regimen (HD-Ara-C, idarubicin)
Drug: cytosine arabinoside

Arm A: use of standard-dose cytosine arabinoside (100 mg/m2/bd iv. on days 1-7) in association with idarubicin and etoposide.

Arm B: use of high-dose cytosine arabinoside (1000-2000 mg/m2/bd according to age +/-65 years iv. on days 1-2 and 8-9) in association with idarubicin.

Other Names:
  • Aracytin
  • Cytarabine
  • Cytosar

Primary Outcome Measures :
  1. Remission induction (R1): Complete remission (CR) rate after cycle 1 [ Time Frame: 30 days after beginning chemotherapy. ]
  2. Remission consolidation (R2): Length of remission (DFS, disease-free survival) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. R1: CR with incomplete hematological recovery [ Time Frame: 30 days after beginning chemotherapy ]
  2. R1:Complete cytogenetic remission [ Time Frame: 30 days after beginning chemotherapy ]
  3. R1: Treatment-related death (TRD) [ Time Frame: 2 months ]
  4. R2: Overall survival (OS) [ Time Frame: 5 years ]
  5. Remission duration and cumulative incidence of relapse [ Time Frame: 5 years ]
  6. Treatment-related death [ Time Frame: 5 years ]
  7. Quality of Life [ Time Frame: 1 year and 3 years ]

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria (Random 1):

  • Age 16+ years
  • Diagnosis of untreated (or only hydroxyurea/cyclophosphamide) acute myelogenous leukemia (AML, including myeloid sarcoma) or high-risk myelodysplasia (RAEB-2), either de novo or following an antecedent hematological disorder, or secondary to chemo-radiotherapy for other cancer
  • Signed informed consent
  • Adequate sampling for full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria
  • ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.

Exclusion criteria:

  • Diagnosis of acute promyelocytic leukemia
  • Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to AML), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to AML), and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan
  • Known HIV positive serology
  • Other active hematological or non-hematological cancers with life expectancy <1 year
  • Pregnancy (fertile women will be advised not to become pregnant while on treatment; and male patients to adopt contraceptive methods)

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): NCT00495287

Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy
USC Ematologia Azienda Papa Giovanni XXIII
Bergamo, BG, Italy
Ospedale Generale di Bolzano
Bolzano, Bz, Italy
S.C. Ematologia - Azienda Ospedaliera S.Croce e Carle
Cuneo, CN, Italy
Ematologia - AOU Careggi
Firenze, FI, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Ematologia Centro TMO - Fondazione IRCSS Ospedale Maggiore
Milano, MI, Italy
Ematologia e TMO - Ospedale San Raffaele
Milano, MI, Italy
Istituto Nazionale Dei Tumori
Milano, MI, Italy
Ematologia - TMO - Ospedale San Gerardo
Monza, MI, Italy
A.O.U San Giovanni Battista-Divisione Ematologica dell'Università
Torino, TO, Italy
Ematologia 2 - Osp. Molinette San Giovanni Battista
Torino, TO, Italy
Ospedale Mauriziano
Torino, TO, Italy
Ospedale dell'Angelo
Mestre, Venezia, Italy
Ospedale Spedali Civili di Brescia
Brescia, Italy
Istituti Ospitalieri
Cremona, Italy
Ospedale di Circolo di Varese
Varese, Italy
Sponsors and Collaborators
Northern Italy Leukemia Group
Principal Investigator: Renato Bassan, MD Norther Italy Leukemia Group

Responsible Party: DR RENATO BASSAN, Medical Doctor, Northern Italy Leukemia Group
ClinicalTrials.gov Identifier: NCT00495287     History of Changes
Other Study ID Numbers: NILG-AML 02/06
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by DR RENATO BASSAN, Northern Italy Leukemia Group:
Acute myelogenous leukemia
Adult patients
Cytogenetic risk class
Clinico-cytogenetic risk model
Risk-oriented therapy

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors