Treatment of Acute Myeloblastic Leukemia in Younger Patients

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00390715

Collaborator

(none)

600

Enrollment

Locations

132

Duration (Months)

14.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloblastic Leukemia	Drug: chemotherapy

Detailed Description

The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease

Study Start Date :

Jan 1, 1999

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age< or =65 years.
ECOG<=3.
AML of new diagnose.
Consent for chemotherapy.

Contacts and Locations

Locations

	Site	City	State	Country
1	Xarxa assistencial de Manresa	Manresa	Barcelona	Spain
2	Hospital general de Castellón	Castello	Castellón	Spain
3	Hospital Universitario de Canarias	Tenerife	Islas Canarias	Spain
4	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	La Coruña	Spain
5	Clínica Universitaria de Navarra	Pamplona	Navarra	Spain
6	Hospital Verge de la Cinta	Tortosa	Tarragona	Spain
7	Hospital General de Alicante	Alicante		Spain
8	Hospital Clínic	Barcelona		Spain
9	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain
10	Hospital del Mar	Barcelona		Spain
11	Hospital Germans Trias i Pujol	Barcelona		Spain
12	Hospital vall d'Hebrón	Barcelona		Spain
13	Hospital Valle Hebrón-Materno Infantil	Barcelona		Spain
14	Complejo Hospitalario de Cáceres	Cáceres		Spain
15	Hospital Puerta del Mar	Cádiz		Spain
16	Complejo Hospitalario Reina Sofía	Córdoba		Spain
17	Hospital Universitario Virgen de las Nieves	Granada		Spain
18	Hospital Virgen de las Nieves	Granada		Spain
19	Area Hospitalaria Juan Ramón Jimenez	Huelva		Spain
20	Hospital general de Jerez de la Frontera	Jerez de la Frontera		Spain
21	Hospital Juan Canalejo	La Coruña		Spain
22	Hospital Virgen Blanca de León	Leon		Spain
23	Fundación Jiménez Díaz	Madrid		Spain
24	Hospital Clínico San Carlos de Madrid	Madrid		Spain
25	Hospital Doce de Octubre	Madrid		Spain
26	Hospital General Universitario Gregorio Marañón, Madrid	Madrid		Spain
27	Hospital Universitario de la Princesa	Madrid		Spain
28	Hospital General Universitario Morales Meseguer.	Murcia		Spain
29	. Hospital Clínico Universitario Virgen de la Victoria	Málaga		Spain
30	Hospital Central de Asturias	Oviedo		Spain
31	Hospital Son Dureta	Palma de Mallorca		Spain
32	Hospital Clínico Universitario de Salamanca	Salamanca		Spain
33	Hospital Universitario Marqués de Valdecilla	Santander		Spain
34	Hospital General de Segovia	Segovia		Spain
35	Hospital Universitario Virgen del Rocío	Sevilla		Spain
36	Hospital Universitari de Tarragona Joan XXIII	Tarragona		Spain
37	Hospital Clínic	Valencia		Spain
38	Hospital La Fe	Valencia		Spain
39	Hospital Universitario Dr. Peset	Valencia		Spain
40	Complejo Hospitalario Xeral-Cies	Vigo		Spain
41	Hospital Txagorritxu	Vitoria		Spain
42	Hospital Clínico Lozano Blesa	Zaragoza		Spain