NCT00400673

Brief Summary

The study was set up to assess:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
581

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2000

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 1, 2011

Status Verified

March 1, 2011

Enrollment Period

7.4 years

First QC Date

November 16, 2006

Last Update Submit

March 31, 2011

Conditions

Acute Myelogenous Leukemia

Keywords

Acute myelogenous leukemiaAdult patientsCytogenetic risk classClinico-cytogenetic risk modelRisk-oriented therapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Percent of patients who are disease-free 5 years from start of therapy

    5-years

Secondary Outcomes (4)

  • Complete remission

    Two months

  • Overall survival

    5 years

  • Cumulative incidence of relapse

    5 years

  • Toxicity

    5 years

Study Arms (1)

Chemotherapy

OTHER

Risk-oriented chemotherapy for remission induction (application of sequential high-dose cytarabine course to patients unresponsive to standard chemotherapy course 1) and postremission consiolidation(standard risk: blood stem cell supported high-dose cytarabine course \[x3\]; high risk: allogeneic SCT)

Behavioral: Two-step remission induction and risk-oriented consolidation

Interventions

Two-step remission induction and risk-oriented consolidationBEHAVIORAL
Chemotherapy

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age 15-65 years,untreated AML (de novo, secondary, myelodysplasia-related, granulocytic sarcoma),untreated high-risk myelodysplasia (RAEB, RAEB-T), informed consent

You may not qualify if:

  • acute promyelocytic leukemia, comorbidity precluding intensive chemotherapy approaches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

USC Ematologia Ospedali Riuniti di Bergamo

Bergamo, BG, 24128, Italy

Location

Divisione Ematologia Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Divisione di Ematologia e TMO Ospedale San Maurizio

Bolzano, BZ, 39100, Italy

Location

Ematologia Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, 12100, Italy

Location

Ematologia e TMO Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Ematologia e TMO Istituto Nazionale dei Tumori

Milan, MI, 20133, Italy

Location

Ematologia-TMO Ospedale San Gerardo

Monza, MI, 20052, Italy

Location

Oncoematologia e TMO Dipartimento Oncologico

Palermo, PA, 90146, Italy

Location

Ematologia 2 Ospedale San Giovanni Battista

Torino, TO, 10126, Italy

Location

Medicina Interna I Ospedale di Circolo

Varese, VA, 21100, Italy

Location

Divisione Ematologia Ospedale Umberto I Mestre

Mestre, VE, 30172, Italy

Location

Dipartimento di Oncologia e di Ematologia Oncologica Regione Veneto ULSS n.13- Presidi Ospedalieri di Noale, Dolo, Mirano

Noale, VE, 30033, Italy

Location

Related Publications (1)

  • Borlenghi E, Cattaneo C, Bertoli D, Cerqui E, Archetti S, Passi A, Oberti M, Zollner T, Giupponi C, Pagani C, Bianchetti N, Bottelli C, Bagnasco S, Sciume M, Tucci A, Rossi G. Prognostic Relevance of NPM1 and FLT3 Mutations in Acute Myeloid Leukaemia, Longterm Follow-Up-A Single Center Experience. Cancers (Basel). 2022 Sep 28;14(19):4716. doi: 10.3390/cancers14194716.

    PMID: 36230640DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Renato Bassan, MD

    Ospedali Riuniti di Bergamo USC Ematologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

May 1, 2000

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

April 1, 2011

Record last verified: 2011-03

Locations

IT(12)