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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Northern Italy Leukemia Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northern Italy Leukemia Group
ClinicalTrials.gov Identifier:
NCT00495287
First received: July 2, 2007
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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 CD34+ 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 Intervention Phase
Acute Myelogenous Leukemia
Drug: cytosine arabinoside
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northern Italy Leukemia Group:

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

Secondary Outcome Measures:
  • R1: CR with incomplete hematological recovery [ Time Frame: 30 days after beginning chemotherapy ] [ Designated as safety issue: No ]
  • R1:Complete cytogenetic remission [ Time Frame: 30 days after beginning chemotherapy ] [ Designated as safety issue: No ]
  • R1: Treatment-related death (TRD) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • R2: Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Remission duration and cumulative incidence of relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Treatment-related death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: November 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495287

Contacts
Contact: Roberto Marchioli, MD +39 0872570250 marchioli@negrisud.it
Contact: Giovanna Borrelli, Dr Sci +39 0872570324 borrelli@negrisud.it

Locations
Italy
Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, AL, Italy
Principal Investigator: Alessandro Levis, MD         
Sub-Investigator: Flavia Salvi, MD         
Sub-Investigator: Lorella Depaoli, MD         
USC Ematologia Ospedali Riuniti di Bergamo Recruiting
Bergamo, BG, Italy
Principal Investigator: Renato Bassan, MD         
Sub-Investigator: Tamara Intermesoli, MD         
Sub-Investigator: Elena Oldani, Dr. Biol Sci         
Sub-Investigator: Federica Delaini, Dr. Biol Sci         
Sub-Investigator: Orietta Spinelli, Dr. Biol Sci         
Sub-Investigator: Vittoria Guerini         
S.C. Ematologia - Azienda Ospedaliera S.Croce e Carle Recruiting
Cuneo, CN, Italy
Principal Investigator: Daniele Mattei, MD         
Sub-Investigator: Andrea Gallamini, MD         
Ematologia - AOU Careggi Recruiting
Firenze, FI, Italy
Principal Investigator: Alberto Bosi, MD         
Sub-Investigator: Franco Leoni, MD         
Sub-Investigator: Giacomo Gianfaldoni, MD         
Sub-Investigator: Francesco Mannelli, MD         
Sub-Investigator: Alessandro Vannucchi, MD         
Ematologia Centro TMO - Fondazione IRCSS Ospedale Maggiore Not yet recruiting
Milano, MI, Italy
Principal Investigator: Giorgio Lambertenghi-Deliliers, MD         
Sub-Investigator: Agostino Cortelezzi, MD         
Sub-Investigator: Maria Cristina Pasquini, MD         
Sub-Investigator: Nicola Fracchiolla, MD         
Sub-Investigator: Claudio Annaloro, MD         
Sub-Investigator: Angelo Gardellini, MD         
Sub-Investigator: Kathrin Von Hohenstaufen, MD         
Ematologia e TMO - Ospedale San Raffaele Recruiting
Milano, MI, Italy
Principal Investigator: Fabio Ciceri, MD         
Sub-Investigator: Massimo Bernardi, MD         
Sub-Investigator: Michela Tassara, MD         
Sub-Investigator: Alessandro Crotta, MD         
Ematologia - TMO - Ospedale San Gerardo Recruiting
Monza, MI, Italy
Principal Investigator: Enrico Pogliani, MD         
Sub-Investigator: Elisabetta Terruzzi, MD         
Sub-Investigator: Matteo Parma, MD         
Sub-Investigator: Monica Fumagalli, MD         
Sub-Investigator: Luisa Verga, MD         
Ematologia 2 - Osp. Molinette San Giovanni Battista Recruiting
Torino, TO, Italy
Principal Investigator: Eugenio Gallo, MD         
Sub-Investigator: Filippo Mormont, MD         
Sub-Investigator: Ernesta Audisio, MD         
Sub-Investigator: Stefano D'Ardia, MD         
Sponsors and Collaborators
Northern Italy Leukemia Group
Investigators
Principal Investigator: Renato Bassan, MD Ospedali Riuniti di Bergamo USC Ematologia
  More Information

No publications provided

Responsible Party: Renato Bassan, MD, Coordinator, Northern Italy Leukemia Group
ClinicalTrials.gov Identifier: NCT00495287     History of Changes
Other Study ID Numbers: NILG-AML 02/06
Study First Received: July 2, 2007
Last Updated: March 31, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by 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
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014