AML Treatment in Untreated Adult Patients (LAM99P)

November 14, 2017 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10

The present therapy intends to be an homogeneous treatment for AML patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with Daunorubicine as according to EORTC-GIMEMA AML10 study.

The post-remissional treatment is based on transplant with HLA compatible donor is foreseen for all patients and autologous transplant for those without HLA compatible donor available.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same anthracycline as in induction on d 4-6. Following consolidation, eligible pts (age <45 or 55 yrs) with a HLA compatible sibling had to be allografted, the others, had to be autografted with autologous peripheral stem cell (PSC) collected during recovery from consolidation.

BM and PB samples at diagnosis were centralized according to a national GIMEMA original study planned with the aim to accurately evaluate biological characteristics at diagnosis and to identify genetic alterations with prognostic relevance and to follow up cases monitoring minimal disease during remission. To allow the adequate collection and sending of samples before starting intensive chemotherapy, all patients received a 5-day pretreatment consisting of hydroxiurea (HU) at the dosage of 2 g/m2/day, also effective for "debulkying" of disease.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Gallarate, Italy
        • Recruiting
        • Prof. Mozzana
      • Latina, Italy
        • Recruiting
        • Dr. De Blasio
      • Lodi, Italy
        • Recruiting
        • Prof. Nalli
      • Milano, Italy
        • Recruiting
        • Prof. Bordigon
      • Napoli, Italy
        • Recruiting
        • Dr Miraglia
      • Napoli, Italy
        • Recruiting
        • Dr. Mettivier
      • Napoli, Italy
        • Recruiting
        • Dr.ssa Mastrullo
      • Napoli, Italy
        • Recruiting
        • Prof. Pane
      • Nocera Inferiore, Italy
        • Recruiting
        • Prof. D'Arco
      • Novara, Italy
        • Recruiting
        • Dr Avanzi
      • Nuoro, Italy
        • Recruiting
        • Dr. Gabbas
      • Orbassano, Italy
        • Recruiting
        • Prof. Saglio
      • Palermo, Italy
        • Recruiting
        • Dr Mirto
      • Palermo, Italy
        • Recruiting
        • Prof. Citarrella
      • Palermo, Italy
        • Recruiting
        • Prof. Mariani
      • Parma, Italy
        • Recruiting
        • Prof. Rizzoli
      • Perugia, Italy
        • Recruiting
        • Pr. Mecucci
      • Perugia, Italy
        • Recruiting
        • Prof. Falini
      • Perugia, Italy
        • Recruiting
        • Prof. Martelli
      • Pescara, Italy
        • Recruiting
        • Dr. Fioritoni
      • Pisa, Italy
        • Recruiting
        • Pr. Petrini
      • Potenza, Italy
        • Recruiting
        • Dr. Ricciuti
      • Reggio Calabria, Italy
        • Recruiting
        • Dr. Nobile
      • Roma, Italy
        • Recruiting
        • Pr. Lo Coco
      • Roma, Italy
        • Recruiting
        • Dr. Andriani
      • Roma, Italy
        • Recruiting
        • Dr. Majolino
      • Roma, Italy
        • Recruiting
        • Pr. Amadori
      • Roma, Italy
        • Recruiting
        • Pr. Annino
      • Roma, Italy
        • Recruiting
        • Pr. Leone
      • Rozzano, Italy
        • Recruiting
        • Dr. Santoro
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Pr. Carella
      • Sassari, Italy
        • Recruiting
        • Pr. Longinotti
      • Sondalo, Italy
        • Recruiting
        • Dr Epis
      • Taormina, Italy
        • Recruiting
        • Dr. Russo
      • Taranto, Italy
        • Recruiting
        • Dr Mazza
      • Torino, Italy
        • Recruiting
        • Pr. Boccadoro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 61 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AML "de novo" with bone marrow blasts <=30%
  • Performance status: 0-3
  • FAB subtype: all except M3
  • Written informed consent

Exclusion Criteria:

  • age <15 years and >= 61 years
  • pretreated AML with chemiotherapy (except Idrossiurea) or radiotherapy or corticosteroids for more than 7 days.
  • diagnosis of acute promyelocitic leukemia (M3)
  • Performance status = 4
  • Uncontrolled infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Franco MANDELLI, Pr., Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 1998

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

March 19, 2007

First Submitted That Met QC Criteria

March 19, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAM99P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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