LAM99P: AML Treatment in Untreated Adult Patients

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Unknown status

CT.gov ID

NCT00449319

Collaborator

(none)

Locations

236

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myelocytic, Acute	Procedure: Identification of appropriate therapies according to risks factors Drug: Daunorubicine Procedure: Transplant	N/A

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 Design

Study Type:

Interventional

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

Actual Study Start Date :

Nov 1, 1998

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 61 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Prof. Mozzana	Gallarate	Italy
2	Dr. De Blasio	Latina	Italy
3	Prof. Nalli	Lodi	Italy
4	Prof. Bordigon	Milano	Italy
5	Dr Miraglia	Napoli	Italy
6	Dr. Mettivier	Napoli	Italy
7	Dr.ssa Mastrullo	Napoli	Italy
8	Prof. Pane	Napoli	Italy
9	Prof. D'Arco	Nocera Inferiore	Italy
10	Dr Avanzi	Novara	Italy
11	Dr. Gabbas	Nuoro	Italy
12	Prof. Saglio	Orbassano	Italy
13	Dr Mirto	Palermo	Italy
14	Prof. Citarrella	Palermo	Italy
15	Prof. Mariani	Palermo	Italy
16	Prof. Rizzoli	Parma	Italy
17	Pr. Mecucci	Perugia	Italy
18	Prof. Falini	Perugia	Italy
19	Prof. Martelli	Perugia	Italy
20	Dr. Fioritoni	Pescara	Italy
21	Pr. Petrini	Pisa	Italy
22	Dr. Ricciuti	Potenza	Italy
23	Dr. Nobile	Reggio Calabria	Italy
24	Dr. Andriani	Roma	Italy
25	Dr. Majolino	Roma	Italy
26	Pr. Amadori	Roma	Italy
27	Pr. Annino	Roma	Italy
28	Pr. Leone	Roma	Italy
29	Pr. Lo Coco	Roma	Italy
30	Dr. Santoro	Rozzano	Italy
31	Pr. Carella	San Giovanni Rotondo	Italy
32	Pr. Longinotti	Sassari	Italy
33	Dr Epis	Sondalo	Italy
34	Dr. Russo	Taormina	Italy
35	Dr Mazza	Taranto	Italy
36	Pr. Boccadoro	Torino	Italy