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AML Treatment in Untreated Adult Patients

NCT ID: NCT00449319

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia, Myelocytic, Acute

Keywords

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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.

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Identification of appropriate therapies according to risks factors

Intervention Type PROCEDURE

Daunorubicine

Intervention Type DRUG

Transplant

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Principal Investigators

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Franco MANDELLI, Pr.

Role: PRINCIPAL_INVESTIGATOR

Gruppo Italiano Malattie EMatologiche dell'Adulto

Locations

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Prof. Mozzana

Gallarate, , Italy

Site Status RECRUITING

Dr. De Blasio

Latina, , Italy

Site Status RECRUITING

Prof. Nalli

Lodi, , Italy

Site Status RECRUITING

Prof. Bordigon

Milan, , Italy

Site Status RECRUITING

Dr Miraglia

Napoli, , Italy

Site Status RECRUITING

Dr. Mettivier

Napoli, , Italy

Site Status RECRUITING

Dr.ssa Mastrullo

Napoli, , Italy

Site Status RECRUITING

Prof. Pane

Napoli, , Italy

Site Status RECRUITING

Prof. D'Arco

Nocera Inferiore, , Italy

Site Status RECRUITING

Dr Avanzi

Novara, , Italy

Site Status RECRUITING

Dr. Gabbas

Nuoro, , Italy

Site Status RECRUITING

Prof. Saglio

Orbassano, , Italy

Site Status RECRUITING

Dr Mirto

Palermo, , Italy

Site Status RECRUITING

Prof. Citarrella

Palermo, , Italy

Site Status RECRUITING

Prof. Mariani

Palermo, , Italy

Site Status RECRUITING

Prof. Rizzoli

Parma, , Italy

Site Status RECRUITING

Pr. Mecucci

Perugia, , Italy

Site Status RECRUITING

Prof. Falini

Perugia, , Italy

Site Status RECRUITING

Prof. Martelli

Perugia, , Italy

Site Status RECRUITING

Dr. Fioritoni

Pescara, , Italy

Site Status RECRUITING

Pr. Petrini

Pisa, , Italy

Site Status RECRUITING

Dr. Ricciuti

Potenza, , Italy

Site Status RECRUITING

Dr. Nobile

Reggio Calabria, , Italy

Site Status RECRUITING

Dr. Andriani

Roma, , Italy

Site Status RECRUITING

Dr. Majolino

Roma, , Italy

Site Status RECRUITING

Pr. Amadori

Roma, , Italy

Site Status RECRUITING

Pr. Annino

Roma, , Italy

Site Status RECRUITING

Pr. Leone

Roma, , Italy

Site Status RECRUITING

Pr. Lo Coco

Roma, , Italy

Site Status RECRUITING

Dr. Santoro

Rozzano, , Italy

Site Status RECRUITING

Pr. Carella

San Giovanni Rotondo, , Italy

Site Status RECRUITING

Pr. Longinotti

Sassari, , Italy

Site Status RECRUITING

Dr Epis

Sondalo, , Italy

Site Status RECRUITING

Dr. Russo

Taormina, , Italy

Site Status RECRUITING

Dr Mazza

Taranto, , Italy

Site Status RECRUITING

Pr. Boccadoro

Torino, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marco VIGNETTI, Dr

Role: CONTACT

Phone: +39 06 441639831

Email: [email protected]

Paola FAZI, Dr.

Role: CONTACT

Phone: +39 06 441639830

Email: [email protected]

Other Identifiers

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LAM99P

Identifier Type: -

Identifier Source: org_study_id