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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00408278
First received: December 5, 2006
Last updated: October 27, 2014
Last verified: October 2014
  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
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

Locations
Poland
PALG
Lodz, Poland
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"
Gerona, Spain
Hospital de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Juan Canalejo
La Coruña, Spain
Hospital Insular de las Palmas
Las Palmas de Gran Canaria, Spain
Complejo Hospitalario León
Leon, 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
Hospital Sta. Maria del Rosell
Murcia, Spain
H. Universitario Virgen de la Victoria
Málaga, Spain
H. Carlos Haya
Málaga, 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
Sevilla, 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, Spain
Hospital Virgen de la Concha
Zamora, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Uruguay
Hospital Maciel
Montevideo, Uruguay
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: October 27, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Promyelocytic Leukemia

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

ClinicalTrials.gov processed this record on November 23, 2014