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Sponsored by: |
PETHEMA Foundation |
Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00408278 |
Primary objectives
Secondary objectives
• To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.
Condition | Intervention | Phase |
Acute Promyelocytic Leukemia |
Drug: ATRA Drug: Idarubicina Drug: Mitoxantrone Drug: ARA-C |
Phase IV |
MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
Drug Information available for: | Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride Mercaptopurine 6-Mercaptopurine Methotrexate Mitoxantrone hydrochloride Mitoxantrone |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005): Remission Induction With ATRA + Idarubicin. Risk-Adapted Consolidation With ATRA and Anthracycline-Based Chemotherapy (Idarubicin/Mitoxantrone) With Addition of Ara-C for High-Risk Patients. Maintenance Therapy With ATRA + Low Dose Chemotherapy (Methotrexate + Mercaptopurine). |
Estimated Enrollment: | 300 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sanz Miguel Angel, Dr | +34 96 197 3057 | msanz@uv.es |
Contact: Vellenga Edo, Dr | +31 (50) 3612354 | e.vellenga@int.azg.nl |
Poland | |||||
PALG | Recruiting | ||||
Lodz, Poland | |||||
Principal Investigator: Holowiecka Alexandra, Dr | |||||
Spain | |||||
Basurtuko Ospitalea | Recruiting | ||||
Bilbao, Spain | |||||
Contact: Beltran de Heredia José Mª, Dr | |||||
Principal Investigator: Beltran de Heredia José Mª, Dr | |||||
Complejo Hospitalario León | Recruiting | ||||
Leon, Spain | |||||
Principal Investigator: Ramos Fernando, Dr | |||||
Complexo Hospitalario Xeral-Calde | Recruiting | ||||
Lugo, Spain | |||||
Principal Investigator: Arias Jesús, Dr | |||||
H. Carlos Haya | Recruiting | ||||
Málaga, Spain | |||||
Principal Investigator: Negri Silvia, Dr | |||||
H. Universitario Virgen de la Victoria | Recruiting | ||||
Málaga, Spain | |||||
Principal Investigator: Perez Inmaculada, Dr | |||||
H.U. Virgen del Rocio | Recruiting | ||||
Sevilla, Spain | |||||
Principal Investigator: Parody Ricardo, Dr | |||||
Hospital "Dr. Trueta" | Recruiting | ||||
Gerona, Spain | |||||
Principal Investigator: Guardia Ramón, Dr | |||||
Hospital 12 de Octubre | Recruiting | ||||
Madrid, Spain | |||||
Principal Investigator: de la Serna Javier, Dr | |||||
Hospital Central de Asturias | Recruiting | ||||
Oviedo, Spain | |||||
Principal Investigator: Rayón Consuelo, Dr | |||||
Hospital General | Recruiting | ||||
Albacete, Spain | |||||
Principal Investigator: Romero Juan Ramón, Dr | |||||
Hospital Clínico de Valladolid | Recruiting | ||||
Valladolid, Spain | |||||
Principal Investigator: Fernandez Calvo Francisco, Dr | |||||
Hospital Clínico San Carlos | Recruiting | ||||
Madrid, Spain | |||||
Principal Investigator: Diaz Mediavilla Joaquín, Dr | |||||
Hospital Clínico Universitario Lozano Blesa | Recruiting | ||||
Zaragoza, Spain | |||||
Principal Investigator: Palomera Luis, Dr | |||||
Hospital de Cruces | Recruiting | ||||
Santander, Spain | |||||
Principal Investigator: Amutio Elena, Dr | |||||
Hospital de Fuenlabrada | Recruiting | ||||
Fuenlabrada, Spain | |||||
Principal Investigator: Hernández José Angel, DR | |||||
Hospital de Navarra | Recruiting | ||||
Pamplona, Spain | |||||
Principal Investigator: Gorosquieta Ana, Dr | |||||
Hospital Joan XXIII | Recruiting | ||||
Tarragona, Spain | |||||
Principal Investigator: Escoda Lourdes, Dr | |||||
Hospital Dr. Peset | Recruiting | ||||
Valencia, Spain | |||||
Principal Investigator: Sayas Mª José | |||||
Hospital general | Recruiting | ||||
Alicante, Spain | |||||
Principal Investigator: Rivas Concha, Dr | |||||
Hospital Clinic | Recruiting | ||||
Barcelona, Spain | |||||
Principal Investigator: Esteve Jordi, Dr | |||||
Hospital general | Recruiting | ||||
Castellon, Spain | |||||
Principal Investigator: Cañigral Guillermo, Dr | |||||
Hospital general | Recruiting | ||||
Valencia, Spain | |||||
Principal Investigator: Linares Mariano, Dr | |||||
Hospital de Jerez de la Frontera | Recruiting | ||||
Jerez de la Frontera, Spain | |||||
Principal Investigator: León Angel, Dr | |||||
Hospital Insular de las Palmas | Recruiting | ||||
Las Palmas de Gran Canaria, Spain | |||||
Principal Investigator: Gonzalez José David, Dr | |||||
Hospital Juan Canalejo | Recruiting | ||||
La Coruña, Spain | |||||
Principal Investigator: Debén Guillermo | |||||
Hospital de Montecelo | Recruiting | ||||
Pontevedra, Spain | |||||
Principal Investigator: Allegue Mª Jose, Dr | |||||
Hospital Severo Ochoa | Recruiting | ||||
Madrid, Spain | |||||
Principal Investigator: Sanchez Godoy Pedro, Dr | |||||
Hospital Reina Sofia | Recruiting | ||||
Madrid, Spain | |||||
Principal Investigator: Rojas Rafael, Dr | |||||
Hospital San Pedro de Alcántara | Recruiting | ||||
Madrid, Spain | |||||
Principal Investigator: Bergua José Mª, Dr | |||||
Hospital de Sant Pau | Recruiting | ||||
Barcelona, Spain | |||||
Principal Investigator: Brunet Salut, Dr | |||||
Hospital Puerta de Hierro | Recruiting | ||||
Madrid, Spain | |||||
Principal Investigator: Kirsnik Isabel, Dr | |||||
Hospital Sta. Maria del Rosell | Recruiting | ||||
Murcia, Spain | |||||
Principal Investigator: Ibañez Jerónima, Dr | |||||
Hospital Txagorritxu | Recruiting | ||||
Vitoria, Spain | |||||
Principal Investigator: Guinea José´Mª, Dr | |||||
Hospital germans Trias i Pujol | Recruiting | ||||
Badalona, Spain | |||||
Principal Investigator: Ribera José Mª, Dr | |||||
Hospital La Fe | Recruiting | ||||
Valencia, Spain | |||||
Principal Investigator: Martinez Jesús, Dr | |||||
Hospital Clínico Universitario | Recruiting | ||||
Salamanca, Spain | |||||
Principal Investigator: González Marcos, Dr | |||||
Hospital Virgen de la Concha | Recruiting | ||||
Zamora, Spain | |||||
Principal Investigator: Martín Alejandro, Dr | |||||
Hospital Dr Negrín | Recruiting | ||||
Palma de Gran Canaria, Spain | |||||
Principal Investigator: Molero Teresa, Dr | |||||
Institut Català d'Oncologái | Recruiting | ||||
Barcelona, Spain | |||||
Principal Investigator: Berlanga Jose, Dr | |||||
Hospital de Santiago de Compostela | Recruiting | ||||
Santiago de Compostela, Spain | |||||
Principal Investigator: Pérez Encina manuel, Dr | |||||
Uruguay | |||||
Hospital Maciel | Recruiting | ||||
Montevideo, Uruguay | |||||
Principal Investigator: De Lisa Elena, Dr |
PETHEMA Foundation |
Study Chair: | San Miguel Miguel Angel, Dr | Hospital La Fe Valencia |
Study Director: | Vellenga Edo, Dr | HOVON |
Study Director: | Lowenberg Bob, Dr | HOVON |
Pethema Foundation web 
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Spanish association of Haematology 
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Hovon Data Center 
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Responsible Party: | Pethema ( Pethema ) |
Study ID Numbers: | LPA 2005 |
First Received: | December 5, 2006 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00408278 |
Health Authority: | Spain: Ministry of Health |
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