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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DR RENATO BASSAN, Northern Italy Leukemia Group
ClinicalTrials.gov Identifier:
NCT00495287
First received: July 2, 2007
Last updated: October 21, 2014
Last verified: October 2014
  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 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 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 2014
Estimated Primary Completion Date: December 2014 (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

Locations
Italy
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 e TMO - Ospedale San Raffaele
Milano, MI, Italy
Ematologia Centro TMO - Fondazione IRCSS Ospedale Maggiore
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&apos;Università
Torino, TO, Italy
Ematologia 2 - Osp. Molinette San Giovanni Battista
Torino, TO, Italy
Ospedale Mauriziano
Torino, TO, Italy
Ospedale dell&apos;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
Investigators
Principal Investigator: Renato Bassan, MD Norther Italy Leukemia Group
  More Information

No publications provided

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
Study First Received: July 2, 2007
Last Updated: October 21, 2014
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
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014