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AML Treatment in Untreated Adult Patients (LAM99P)

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00449319
First received: March 19, 2007
Last updated: March 22, 2007
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention
Leukemia, Myelocytic, Acute
 Procedure: Identification of appropriate therapies according to risks factors
Drug: Daunorubicine
Procedure: Transplant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Study Start Date: November 1998
Study Completion Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   15 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449319

Locations
Italy
Prof. Mozzana
Gallarate, Italy
Dr. De Blasio
Latina, Italy
Prof. Nalli
Lodi, Italy
Prof. Bordigon
Milano, Italy
Dr Miraglia
Napoli, Italy
Dr.ssa Mastrullo
Napoli, Italy
Dr. Mettivier
Napoli, Italy
Prof. Pane
Napoli, Italy
Prof. D'Arco
Nocera Inferiore, Italy
Dr Avanzi
Novara, Italy
Dr. Gabbas
Nuoro, Italy
Prof. Saglio
Orbassano, Italy
Prof. Citarrella
Palermo, Italy
Prof. Mariani
Palermo, Italy
Dr Mirto
Palermo, Italy
Prof. Rizzoli
Parma, Italy
Prof. Martelli
Perugia, Italy
Prof. Falini
Perugia, Italy
Pr. Mecucci
Perugia, Italy
Dr. Fioritoni
Pescara, Italy
Pr. Petrini
Pisa, Italy
Dr. Ricciuti
Potenza, Italy
Dr. Nobile
Reggio Calabria, Italy
Pr. Leone
Roma, Italy
Dr. Majolino
Roma, Italy
Pr. Amadori
Roma, Italy
Dr. Andriani
Roma, Italy
Pr. Annino
Roma, Italy
Pr. Lo Coco
Roma, Italy
Dr. Santoro
Rozzano, Italy
Pr. Carella
San Giovanni Rotondo, Italy
Pr. Longinotti
Sassari, Italy
Dr Epis
Sondalo, Italy
Dr. Russo
Taormina, Italy
Dr Mazza
Taranto, Italy
Pr. Boccadoro
Torino, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Franco MANDELLI, Pr. Gruppo Italiano Malattie EMatologiche dell'Adulto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00449319     History of Changes
Other Study ID Numbers: LAM99P
Study First Received: March 19, 2007
Last Updated: March 22, 2007
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
AML
adult
Hydroxyurea
Transplant
Toevaluate biological characteristics at diagnosis.
 To identify genetic alterations with prognostic relevance.
To follow up cases monitoring minimal disease during remission.
To evaluate pretreatment therapy in terms of response rate and toxicity.
Disease free survival.
Overal survival.

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013