Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
- Conditions
- Acute Promyelocytic Leukemia
- Registration Number
- NCT00408278
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
Primary objectives
* To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
* To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL.
* To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse.
* To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.
Secondary objectives
• To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.
- Detailed Description
Treatment of induction with the simultaneous administration of ATRA (45 mg/m2 day until the RC) and idarubicine (12 mg/m2 days 2, 4, 6 and 8), 3 monthly cycles of consolidation with ATRA (45 mg/m2 days 1-15) and idarubicine (5 mg/m2 days 1-4) in the cycle #1, mitoxantrone (10 mg/m2 days 1-3) in the cycle #2 and idarubicine (12 mg/m2 day 1) in the cycle #3. The consolidation was reinforced for the group of patients with intermediate risk by means of an increase of the idarubicine to 7 mg in the cycle #1 and to 2 days in the cycle #3. In the patients of high risk, the consolidation was reinforced with the addition of altar-c in the cycles #1 and #3. For the maintenance treatment, one will administer to intermittent ATRA (15 days every 3 months) and chemotherapy low doses with methotrexate and 6-mercaptopurina during two years
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Age ≤ 75 years.
- ECOG ≤ 3.
- Morphologic Diagnosis of LPA (FAB M3 or variant M3). Those cases without typical morphology but with PML-RARα reordering also must be including.
- Genetic Diagnosis: t (15; 17) demonstrated by cariotipo conventional, FISH, PML-RARα reordering detected by RT-PCR or a pattern microspeckled demonstrated with antibody anti-PML (positive PGM3). Obvious, it will be had the result of these tests once initiated the treatment on the basis of a suspicion diagnoses morphologic
- Age >75 years (the treatment with this protocol can be considered individually)
- Absence of PML-Rare reordering.
- To have received previously some type of treatment for LPA, including chemotherapy or retinoides. The previous treatment with corticoids, hidroxiurea or leucoaféresis is not reason for exclusion.
- To have received chemotherapy or x-ray for the treatment of a disease vitiates previous.
- Associate Neoplasia.
- Serious psychiatric Disease.
- Seropositividad for VIH.
- Contraindication to receive intensive chemotherapy, specially antraciclinas.
- Sérica Creatinina ≥ 2,5 mg/dL (≥ 250 μmol/l).
- Bilirrubina, fosfatasa alkaline, or GOT > 3 times the normal limit
- Test of positive pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. 1 year To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival. 1 year To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients on the event-free, disease-free, and overall survival 1 year To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL. 1 year
- Secondary Outcome Measures
Name Time Method To compare all outcomes with those achieved with the PETHEMA LPA99 protocol. 2 years
Trial Locations
- Locations (40)
Hospital La Fe
🇪🇸Valencia, Spain
Hospital de Cruces
🇪🇸Santander, Spain
Hospital de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Hospital general
🇪🇸Valencia, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Insular de las Palmas
🇪🇸Las Palmas de Gran Canaria, Spain
H. Carlos Haya
🇪🇸Málaga, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Hospital Severo Ochoa
🇪🇸Madrid, Spain
Hospital de Navarra
🇪🇸Pamplona, Spain
Hospital Sta. Maria del Rosell
🇪🇸Murcia, Spain
H.U. Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Maciel
🇺🇾Montevideo, Uruguay
Hospital Dr Negrín
🇪🇸Palma de Gran Canaria, Spain
H. Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Clínico Universitario
🇪🇸Salamanca, Spain
Hospital de Montecelo
🇪🇸Pontevedra, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
Hospital Virgen de la Concha
🇪🇸Zamora, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
PALG
🇵🇱Lodz, Poland
Hospital General
🇪🇸Albacete, Spain
Hospital de Sant Pau
🇪🇸Barcelona, Spain
Hospital germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
Basurtuko Ospitalea
🇪🇸Bilbao, Spain
Institut Català d'Oncologái
🇪🇸Barcelona, Spain
Hospital de Fuenlabrada
🇪🇸Fuenlabrada, Spain
Hospital Juan Canalejo
🇪🇸La Coruña, Spain
Hospital "Dr. Trueta"
🇪🇸Gerona, Spain
Hospital de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Spain
Complejo Hospitalario León
🇪🇸Leon, Spain
Complexo Hospitalario Xeral-Calde
🇪🇸Lugo, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital San Pedro de Alcántara
🇪🇸Madrid, Spain
Hospital Reina Sofia
🇪🇸Madrid, Spain