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Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

Phase 4
Completed
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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 survival1 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
NameTimeMethod
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

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