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

NCT ID: NCT00408278

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2013-12-31

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

Conditions

Acute Promyelocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ATRA

45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months

Intervention Type: DRUG

Idarubicina

Induction: 12 mg/m2 days 2, 4, 6 and 8 Consolidation: 5 mg/m2 days 1-4 in cycle 1 and 12 mg/m2 day 1 in cycle 3.

Intervention Type: DRUG

Mitoxantrone

Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2

Intervention Type: DRUG

ARA-C

In high risk patients, consolidation with ara-C in cycles 1 and 3.

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PETHEMA Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

San Miguel Miguel Angel, Dr

Role: STUDY_CHAIR

Hospital La Fe de Valencia

Vellenga Edo, Dr

Role: STUDY_DIRECTOR

Stichting Hemato-Oncologie voor Volwassenen Nederland

Lowenberg Bob, Dr

Role: STUDY_DIRECTOR

Stichting Hemato-Oncologie voor Volwassenen Nederland

Locations

PALG

Lodz, , Poland

Hospital Juan Canalejo

A Coruña, , Spain

Hospital General

Albacete, , Spain

Hospital general

Alicante, , Spain

Hospital germans Trias i Pujol

Badalona, , Spain

Hospital Clinic

Barcelona, , Spain

Hospital de Sant Pau

Barcelona, , Spain

Institut Català d'Oncologái

Barcelona, , Spain

Basurtuko Ospitalea

Bilbao, , Spain

Hospital general

Castellon, , Spain

Hospital de Fuenlabrada

Fuenlabrada, , Spain

Hospital "Dr. Trueta"

Girona, , Spain

Hospital de Jerez de la Frontera

Jerez de la Frontera, , Spain

Hospital Insular de las Palmas

Las Palmas de Gran Canaria, , Spain

Complejo Hospitalario León

León, , Spain

Complexo Hospitalario Xeral-Calde

Lugo, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Puerta de Hierro

Madrid, , Spain

Hospital Reina Sofia

Madrid, , Spain

Hospital San Pedro de Alcántara

Madrid, , Spain

Hospital Severo Ochoa

Madrid, , Spain

H. Carlos Haya

Málaga, , Spain

H. Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Sta. Maria del Rosell

Murcia, , Spain

Hospital Central de Asturias

Oviedo, , Spain

Hospital Dr Negrín

Palma de Gran Canaria, , Spain

Hospital de Navarra

Pamplona, , Spain

Hospital de Montecelo

Pontevedra, , Spain

Hospital Clínico Universitario

Salamanca, , Spain

Hospital de Cruces

Santander, , Spain

Hospital de Santiago de Compostela

Santiago de Compostela, , Spain

H.U. Virgen del Rocio

Seville, , Spain

Hospital Joan XXIII

Tarragona, , Spain

Hospital Dr. Peset

Valencia, , Spain

Hospital general

Valencia, , Spain

Hospital La Fe

Valencia, , Spain

Hospital Clínico de Valladolid

Valladolid, , Spain

Hospital Txagorritxu

Vitoria-Gasteiz, , Spain

Hospital Virgen de la Concha

Zamora, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Hospital Maciel

Montevideo, , Uruguay

Countries

Poland; Spain; Uruguay

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Related Links

http://www.aehh.org

Spanish association of Haematology

http://www.hovon.nl

Hovon Data Center

Other Identifiers

LPA 2005

Identifier Type: -

Identifier Source: org_study_id