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Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase IV | Treatment | Active | 0 to 75 | LPA 2005
NCT00408278 |
Trial Description
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.
Further Study Information 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
Eligibility Criteria Inclusion Criteria: - 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.
- Serious psychiatric Disease.
- 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.
Trial Contact Information
Trial Lead Organizations/Sponsors Program for the Study and Treatment of Hematological Malignancies | San Miguel Miguel Angel, Dr | | Study Chair |
| Vellenga Edo, Dr | | Study Director |
| Bob Loewenberg | | Study Director |
| Sanz Miguel Angel, Dr | | Ph: +34 96 197 3057 | | |
Email:
msanz@uv.es |
Trial Sites
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| Poland |
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Lodz |
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| | | | | | | | Medical University of Lodz |
| | | Holowiecka Alexandra, Dr | Principal Investigator |
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| Spain |
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Albacete |
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| | | | Hospital General de Albacete |
| | | Romero Juan Ramón, Dr | Principal Investigator |
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Alicante |
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| | | Hospital General - Alicante |
| | | Rivas Concha, Dr | Principal Investigator |
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Badalona |
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| | | Hospital Universitari Germans Trias i Pujol |
| | | Ribera José Mª, Dr | Principal Investigator |
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Barcelona |
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| | | Hospital Clinic de Barcelona |
| | | Esteve Jordi, Dr | Principal Investigator |
| | | Hospital de la Santa Cruz i Sant Pau |
| | | Brunet Salut, Dr | Principal Investigator |
| | | Institut Catala D'Oncologia |
| | | Berlanga Jose, Dr | Principal Investigator |
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Bilbao |
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| | | Hospital de Basurto |
| | | Beltran de Heredia José Mª, Dr | |
| | | Beltran de Heredia José Mª, Dr | Principal Investigator |
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Castellon |
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| | | Hospital General de Castellon |
| | | Cañigral Guillermo, Dr | Principal Investigator |
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Fuenlabrada |
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| | | Hospital Universitario de Fuenlabrada |
| | | Hernández José Angel, DR | Principal Investigator |
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Gerona |
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| | | Hospital Universitari Josep Trueta de Girona |
| | | Guardia Ramón, Dr | Principal Investigator |
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Jerez de la Frontera |
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| | | Hospital General de Jerez de la Frontera |
| | | León Angel, Dr | Principal Investigator |
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La Coruña |
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| | | Hospital Universitario Juan Canalejo |
| | | Debén Guillermo | Principal Investigator |
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Las Palmas de Gran Canaria |
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| | | Hospital Universitario Insular de Gran Canaria |
| | | Gonzalez José David, Dr | Principal Investigator |
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Leon |
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| | | Complejo Hospitalario de Leon |
| | | Ramos Fernando, Dr | Principal Investigator |
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Lugo |
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| | | Hospital Xeral de Lugo |
| | | Arias Jesús, Dr | Principal Investigator |
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Madrid |
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| | | Clinica Puerta de Hierro |
| | | Kirsnik Isabel, Dr | Principal Investigator |
| | | Hospital San Pedro de Alcantara |
| | | Bergua José Mª, Dr | Principal Investigator |
| | | Hospital Severo Ochoa |
| | | Sanchez Godoy Pedro, Dr | Principal Investigator |
| | | Hospital Universarito Reina Sofia |
| | | Rojas Rafael, Dr | Principal Investigator |
| | | Hospital Universitario 12 de Octubre |
| | | de la Serna Javier, Dr | Principal Investigator |
| | | Hospital Universitario San Carlos |
| | | Diaz Mediavilla Joaquín, Dr | Principal Investigator |
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Málaga |
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| | | Hospital Regional Carlos Haya De Malaga |
| | | Negri Silvia, Dr | Principal Investigator |
| | | Hospital Universitario Virgen de la Victoria |
| | | Perez Inmaculada, Dr | Principal Investigator |
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Murcia |
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| | | Hospital Santa Maria del Rosell |
| | | Ibañez Jerónima, Dr | Principal Investigator |
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Oviedo |
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| | | Hospital Universitario Central de Asturias |
| | | Rayón Consuelo, Dr | Principal Investigator |
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Palma de Gran Canaria |
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| | | Hospital de Gran Canaria Dr. Negrin |
| | | Molero Teresa, Dr | Principal Investigator |
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Pamplona |
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| | | Clinica Universitaria |
| | | Gorosquieta Ana, Dr | Principal Investigator |
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Pontevedra |
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| | | Hospital Montecelo de Pontevedra |
| | | Allegue Mª Jose, Dr | Principal Investigator |
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Salamanca |
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| | | University Hospital - Salamanca |
| | | González Marcos, Dr | Principal Investigator |
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Santander |
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| | | Hospital de Cruces |
| | | Amutio Elena, Dr | Principal Investigator |
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Santiago de Compostela |
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| | | Santiago de Compostela University Hospital |
| | | Pérez Encina manuel, Dr | Principal Investigator |
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Sevilla |
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| | | Hospital Universidad Virgen Del Rocio |
| | | Parody Ricardo, Dr | Principal Investigator |
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Tarragona |
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| | | Hospital Universitari de Tarragona Joan XXIII |
| | | Escoda Lourdes, Dr | Principal Investigator |
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Valencia |
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| | | Hospital General Universitario Valencia |
| | | Linares Mariano, Dr | Principal Investigator |
| | | Hospital Universitario Dr. Peset |
| | | Sayas Mª José | Principal Investigator |
| | | Hospital Universitario La Fe |
| | | Martinez Jesús, Dr | Principal Investigator |
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Valladolid |
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| | | Universidad de Valladolid |
| | | Fernandez Calvo Francisco, Dr | Principal Investigator |
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Vitoria |
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| | | Hospital Txagorritxu |
| | | Guinea José´Mª, Dr | Principal Investigator |
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Zamora |
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| | | Hospital Virgen de la Concha |
| | | Martín Alejandro, Dr | Principal Investigator |
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Zaragoza |
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| | | Hospital Clinico Universitario Lozano Blesa |
| | | Palomera Luis, Dr | Principal Investigator |
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| Uruguay |
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Montevideo |
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| | | | Hospital Maciel |
| | | De Lisa Elena, Dr | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00408278
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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