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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by PETHEMA Foundation
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00408278
First received: December 5, 2006
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Acute Promyelocytic Leukemia
Drug: ATRA
Drug: Idarubicina
Drug: Mitoxantrone
Drug: ARA-C
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare all outcomes with those achieved with the PETHEMA LPA99 protocol. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2005
Estimated Study Completion Date: December 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ATRA
    45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months
    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.
    Drug: Mitoxantrone
    Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2
    Drug: ARA-C
    In high risk patients, consolidation with ara-C in cycles 1 and 3.
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

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408278

Contacts
Contact: Sanz Miguel Angel, Dr +34 96 197 3057 msanz@uv.es
Contact: Vellenga Edo, Dr +31 (50) 3612354 e.vellenga@int.azg.nl

Locations
Poland
PALG Recruiting
Lodz, Poland
Principal Investigator: Holowiecka Alexandra, Dr         
Spain
Hospital General Recruiting
Albacete, Spain
Principal Investigator: Romero Juan Ramón, Dr         
Hospital general Recruiting
Alicante, Spain
Principal Investigator: Rivas Concha, Dr         
Hospital germans Trias i Pujol Recruiting
Badalona, Spain
Principal Investigator: Ribera José Mª, Dr         
Hospital Clinic Recruiting
Barcelona, Spain
Principal Investigator: Esteve Jordi, Dr         
Institut Català d'Oncologái Recruiting
Barcelona, Spain
Principal Investigator: Berlanga Jose, Dr         
Hospital de Sant Pau Recruiting
Barcelona, Spain
Principal Investigator: Brunet Salut, Dr         
Basurtuko Ospitalea Recruiting
Bilbao, Spain
Contact: Beltran de Heredia José Mª, Dr         
Principal Investigator: Beltran de Heredia José Mª, Dr         
Hospital general Recruiting
Castellon, Spain
Principal Investigator: Cañigral Guillermo, Dr         
Hospital de Fuenlabrada Recruiting
Fuenlabrada, Spain
Principal Investigator: Hernández José Angel, DR         
Hospital "Dr. Trueta" Recruiting
Gerona, Spain
Principal Investigator: Guardia Ramón, Dr         
Hospital de Jerez de la Frontera Recruiting
Jerez de la Frontera, Spain
Principal Investigator: León Angel, Dr         
Hospital Juan Canalejo Recruiting
La Coruña, Spain
Principal Investigator: Debén Guillermo         
Hospital Insular de las Palmas Recruiting
Las Palmas de Gran Canaria, Spain
Principal Investigator: Gonzalez José David, Dr         
Complejo Hospitalario León Recruiting
Leon, Spain
Principal Investigator: Ramos Fernando, Dr         
Complexo Hospitalario Xeral-Calde Recruiting
Lugo, Spain
Principal Investigator: Arias Jesús, Dr         
Hospital Severo Ochoa Recruiting
Madrid, Spain
Principal Investigator: Sanchez Godoy Pedro, Dr         
Hospital 12 de Octubre Recruiting
Madrid, Spain
Principal Investigator: de la Serna Javier, Dr         
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Principal Investigator: Diaz Mediavilla Joaquín, Dr         
Hospital Reina Sofia Recruiting
Madrid, Spain
Principal Investigator: Rojas Rafael, Dr         
Hospital Puerta de Hierro Recruiting
Madrid, Spain
Principal Investigator: Kirsnik Isabel, Dr         
Hospital San Pedro de Alcántara Recruiting
Madrid, Spain
Principal Investigator: Bergua José Mª, Dr         
Hospital Sta. Maria del Rosell Recruiting
Murcia, Spain
Principal Investigator: Ibañez Jerónima, Dr         
H. Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Principal Investigator: Perez Inmaculada, Dr         
H. Carlos Haya Recruiting
Málaga, Spain
Principal Investigator: Negri Silvia, Dr         
Hospital Central de Asturias Recruiting
Oviedo, Spain
Principal Investigator: Rayón Consuelo, Dr         
Hospital Dr Negrín Recruiting
Palma de Gran Canaria, Spain
Principal Investigator: Molero Teresa, Dr         
Hospital de Navarra Recruiting
Pamplona, Spain
Principal Investigator: Gorosquieta Ana, Dr         
Hospital de Montecelo Recruiting
Pontevedra, Spain
Principal Investigator: Allegue Mª Jose, Dr         
Hospital Clínico Universitario Recruiting
Salamanca, Spain
Principal Investigator: González Marcos, Dr         
Hospital de Cruces Recruiting
Santander, Spain
Principal Investigator: Amutio Elena, Dr         
Hospital de Santiago de Compostela Recruiting
Santiago de Compostela, Spain
Principal Investigator: Pérez Encina manuel, Dr         
H.U. Virgen del Rocio Recruiting
Sevilla, Spain
Principal Investigator: Parody Ricardo, Dr         
Hospital Joan XXIII Recruiting
Tarragona, Spain
Principal Investigator: Escoda Lourdes, Dr         
Hospital Dr. Peset Recruiting
Valencia, Spain
Principal Investigator: Sayas Mª José         
Hospital La Fe Recruiting
Valencia, Spain
Principal Investigator: Martinez Jesús, Dr         
Hospital general Recruiting
Valencia, Spain
Principal Investigator: Linares Mariano, Dr         
Hospital Clínico de Valladolid Recruiting
Valladolid, Spain
Principal Investigator: Fernandez Calvo Francisco, Dr         
Hospital Txagorritxu Recruiting
Vitoria, Spain
Principal Investigator: Guinea José´Mª, Dr         
Hospital Virgen de la Concha Recruiting
Zamora, Spain
Principal Investigator: Martín Alejandro, Dr         
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain
Principal Investigator: Palomera Luis, Dr         
Uruguay
Hospital Maciel Recruiting
Montevideo, Uruguay
Principal Investigator: De Lisa Elena, Dr         
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: San Miguel Miguel Angel, Dr HOSPITAL LA FE VALENCIA
Study Director: Vellenga Edo, Dr Stichting Hemato-Oncologie voor Volwassenen Nederland
Study Director: Lowenberg Bob, Dr Stichting Hemato-Oncologie voor Volwassenen Nederland
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00408278     History of Changes
Other Study ID Numbers: LPA 2005
Study First Received: December 5, 2006
Last Updated: November 19, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Promyelocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Cytarabine
Mitoxantrone
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014