Acute Myelogenous Leukemia Clinical Trial
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
Verified date | March 2011 |
Source | Northern Italy Leukemia Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
The study was set up to assess:
1. A two-step, increasing-intensity remission induction phase. A conventional chemotherapy
course (ICE, plus G-CSF) was followed, in unresponsive patients, by sequential
high-dose cytarabine (plus G-CSF), aiming to provide an early effective rescue to as
many refractory cases as possible.
2. A risk-oriented postremission consolidation phase. The objective was to adopt
allogeneic stem cell transplantation (alloSCT) in high-risk (HR) cases, while
standard-risk (SR) ones were consolidated with a multicycle high-dose
cytarabine-containing program, which included the use of autologous stem cells plus
G-CSF to limit drug-related toxicity and intercycle treatment delays.
Status | Completed |
Enrollment | 581 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age 15-65 years,untreated AML (de novo, secondary, myelodysplasia-related, granulocytic sarcoma),untreated high-risk myelodysplasia (RAEB, RAEB-T), informed consent Exclusion Criteria: - acute promyelocytic leukemia, comorbidity precluding intensive chemotherapy approaches |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | USC Ematologia Ospedali Riuniti di Bergamo | Bergamo | BG |
Italy | Divisione di Ematologia e TMO Ospedale San Maurizio | Bolzano | BZ |
Italy | Divisione Ematologia Spedali Civili di Brescia | Brescia | BS |
Italy | Ematologia Azienda Ospedaliera S. Croce e Carle | Cuneo | CN |
Italy | Divisione Ematologia Ospedale Umberto I Mestre | Mestre | VE |
Italy | Ematologia e TMO Istituto Nazionale dei Tumori | Milano | MI |
Italy | Ematologia e TMO Ospedale San Raffaele | Milano | MI |
Italy | Ematologia-TMO Ospedale San Gerardo | Monza | MI |
Italy | Dipartimento di Oncologia e di Ematologia Oncologica Regione Veneto ULSS n.13- Presidi Ospedalieri di Noale, Dolo, Mirano | Noale | VE |
Italy | Oncoematologia e TMO Dipartimento Oncologico | Palermo | PA |
Italy | Ematologia 2 Ospedale San Giovanni Battista | Torino | TO |
Italy | Medicina Interna I Ospedale di Circolo | Varese | VA |
Lead Sponsor | Collaborator |
---|---|
Northern Italy Leukemia Group |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival | Percent of patients who are disease-free 5 years from start of therapy | 5-years | No |
Secondary | Complete remission | Percent of patients who achieve complete remission within two months from start of therapy (i.e. after two chemotherapy cycles) | Two months | No |
Secondary | Overall survival | Percent of patients who are alive 5 years after diagnosis | 5 years | No |
Secondary | Cumulative incidence of relapse | Percent of patients who suffer from leukemia relapse at 5 years from date of remission | 5 years | No |
Secondary | Toxicity | Percent of patients who die of treatment-related complications (in different prognostic/treatment groups)until 5 years from start of therapy | 5 years | Yes |
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