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AML Treatment in Untreated Adult Patients (LAM99P)

This study is currently recruiting participants.
Verified November 2017 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449319
First Posted: March 20, 2007
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10

Resource links provided by NLM:


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

Actual Study Start Date: November 1998
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 61 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449319


Contacts
Contact: Marco VIGNETTI, Dr +39 06 441639831 m.vignetti@gimema.it
Contact: Paola FAZI, Dr. +39 06 441639830 p.fazi@gimema.it

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

ClinicalTrials.gov Identifier: NCT00449319     History of Changes
Other Study ID Numbers: LAM99P
First Submitted: March 19, 2007
First Posted: March 20, 2007
Last Update Posted: November 15, 2017
Last Verified: November 2017

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, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action