AML Treatment in Untreated Adult Patients

Leukemia, Myelocytic, Acute Clinical Trial

— LAM99P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00449319
• Other study ID #: LAM99P
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2007
• Last updated: November 14, 2017
• Start date: November 1998
• Est. completion date: July 2018

Study information

• Verified date: November 2017
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Marco VIGNETTI, Dr
• Phone: +39 06 441639831
• Email: m.vignetti[@]gimema.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• Identification of appropriate therapies according to risks factors

Drug:
• Daunorubicine

Procedure:
• Transplant

Locations

Country	Name	City	State
Italy	Prof. Mozzana	Gallarate
Italy	Dr. De Blasio	Latina
Italy	Prof. Nalli	Lodi
Italy	Prof. Bordigon	Milano
Italy	Dr Miraglia	Napoli
Italy	Dr. Mettivier	Napoli
Italy	Dr.ssa Mastrullo	Napoli
Italy	Prof. Pane	Napoli
Italy	Prof. D'Arco	Nocera Inferiore
Italy	Dr Avanzi	Novara
Italy	Dr. Gabbas	Nuoro
Italy	Prof. Saglio	Orbassano
Italy	Dr Mirto	Palermo
Italy	Prof. Citarrella	Palermo
Italy	Prof. Mariani	Palermo
Italy	Prof. Rizzoli	Parma
Italy	Pr. Mecucci	Perugia
Italy	Prof. Falini	Perugia
Italy	Prof. Martelli	Perugia
Italy	Dr. Fioritoni	Pescara
Italy	Pr. Petrini	Pisa
Italy	Dr. Ricciuti	Potenza
Italy	Dr. Nobile	Reggio Calabria
Italy	Dr. Andriani	Roma
Italy	Dr. Majolino	Roma
Italy	Pr. Amadori	Roma
Italy	Pr. Annino	Roma
Italy	Pr. Leone	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy,