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Sponsored by: |
Northern Italy Leukemia Group |
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Information provided by: | Northern Italy Leukemia Group |
ClinicalTrials.gov Identifier: | NCT00400673 |
The study was set up to assess:
Condition | Intervention | Phase |
---|---|---|
Acute Myelogenous Leukemia |
Behavioral: Two-step remission induction and risk-oriented consolidation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Two-Step Remission Induction With Risk-Oriented Consolidation (High-Risk: Allogeneic Stem Cell Transplant; Standard-Risk: Multicycle High-Dose Cytarabine With Autologous Blood Stem Cell Support) for Adult Acute Myelogenous Leukemia |
Estimated Enrollment: | 250 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | June 2006 |
Adult AML is a difficult-to-treat illness because of both biological and therapeutic reasons.
As to the first point, many patients are aged >50 years and/or present with significant comorbidity and/or AML-related risk features (poor risk cytogenetics, prior myelodysplasia, secondary AML).
As to the second point, standard-type remission induction therapy is ineffective in 20% or more of the patients, whereas the application of the more effective postremission consolidation options (alloSCT, high-dose cytarabine courses) is often flawed by high-grade toxicity which can offset expected benefits, particularly in older age groups (>50-55 years), where therapy-related death rates are seen in 5%-10% of the cases (chemotherapy) or more (transplants).
Against this background an explorative study was developed in which:
total WBC >50x10e9/l, FAB subtype M0, M6 or M7, prior myelodysplasia or secondary AML,hepatosplenomegaly, late CR (cycle 2), or favorable cytogenetics with late CR (cycle 2). SR: favorable cytogenetics (without associated high-risk abnormalities and in CR after cycle 1) or intermediate-risk/normal cytogenetics without FLT3 mutation and/or without any one additional clinical risk factor(s), i.e. total WBC >50x10e9/l, FAB subtype M0, M6 or M7, prior myelodysplasia or secondary AML,hepatosplenomegaly, late CR (cycle 2).
Ages Eligible for Study: | 15 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy, BG | |
USC Ematologia Ospedali Riuniti di Bergamo | |
Bergamo, BG, Italy, 24128 | |
Italy, BS | |
Divisione Ematologia Spedali Civili di Brescia | |
Brescia, BS, Italy, 25123 | |
Italy, BZ | |
Divisione di Ematologia e TMO Ospedale San Maurizio | |
Bolzano, BZ, Italy, 39100 | |
Italy, CN | |
Ematologia Azienda Ospedaliera S. Croce e Carle | |
Cuneo, CN, Italy, 12100 | |
Italy, MI | |
Ematologia e TMO Ospedale San Raffaele | |
Milano, MI, Italy, 20132 | |
Ematologia-TMO Ospedale San Gerardo | |
Monza, MI, Italy, 20052 | |
Ematologia e TMO Istituto Nazionale dei Tumori | |
Milano, MI, Italy, 20133 | |
Italy, PA | |
Oncoematologia e TMO Dipartimento Oncologico | |
Palermo, PA, Italy, 90146 | |
Italy, to | |
Ematologia 2 Ospedale San Giovanni Battista | |
Torino, to, Italy, 10126 | |
Italy, VA | |
Medicina Interna I Ospedale di Circolo | |
Varese, VA, Italy, 21100 | |
Italy, VE | |
Divisione Ematologia Ospedale Umberto I Mestre | |
Mestre, VE, Italy, 30172 | |
Dipartimento di Oncologia e di Ematologia Oncologica Regione Veneto ULSS n.13- Presidi Ospedalieri di Noale, Dolo, Mirano | |
Noale, VE, Italy, 30033 |
Principal Investigator: | Renato Bassan, MD | Ospedali Riuniti di Bergamo USC Ematologia |
Study ID Numbers: | NILG-AML 01/00 |
Study First Received: | November 16, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00400673 History of Changes |
Health Authority: | Italy: Ministry of Health |
Acute myelogenous leukemia Adult patients Cytogenetic risk class Clinico-cytogenetic risk model Risk-oriented therapy |
Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult |
Leukemia, Myeloid Leukemia, Myeloid, Acute Cytarabine |
Leukemia Neoplasms Neoplasms by Histologic Type Leukemia, Myeloid Leukemia, Myeloid, Acute |