Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
Primary Purpose
Acute Promyelocytic Leukemia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ATRA
Idarubicina
Mitoxantrone
ARA-C
Sponsored by
About this trial
This is an interventional treatment trial for Acute Promyelocytic Leukemia focused on measuring Acute Promyelocytic Leukemia
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.
Sites / Locations
- PALG
- Hospital General
- Hospital general
- Hospital germans Trias i Pujol
- Hospital Clinic
- Hospital de Sant Pau
- Institut Català d'Oncologái
- Basurtuko Ospitalea
- Hospital general
- Hospital de Fuenlabrada
- Hospital "Dr. Trueta"
- Hospital de Jerez de la Frontera
- Hospital Juan Canalejo
- Hospital Insular de las Palmas
- Complejo Hospitalario León
- Complexo Hospitalario Xeral-Calde
- Hospital 12 de Octubre
- Hospital Clínico San Carlos
- Hospital Puerta de Hierro
- Hospital Reina Sofia
- Hospital San Pedro de Alcántara
- Hospital Severo Ochoa
- Hospital Sta. Maria del Rosell
- H. Carlos Haya
- H. Universitario Virgen de la Victoria
- Hospital Central de Asturias
- Hospital Dr Negrín
- Hospital de Navarra
- Hospital de Montecelo
- Hospital Clínico Universitario
- Hospital de Cruces
- Hospital de Santiago de Compostela
- H.U. Virgen del Rocio
- Hospital Joan XXIII
- Hospital Dr. Peset
- Hospital general
- Hospital La Fe
- Hospital Clínico de Valladolid
- Hospital Txagorritxu
- Hospital Virgen de la Concha
- Hospital Clínico Universitario Lozano Blesa
- Hospital Maciel
Outcomes
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.
To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival.
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
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 Outcome Measures
To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00408278
Brief Title
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
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).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Promyelocytic Leukemia
Keywords
Acute Promyelocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ATRA
Intervention Description
45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months
Intervention Type
Drug
Intervention Name(s)
Idarubicina
Intervention Description
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
Intervention Name(s)
Mitoxantrone
Intervention Description
Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2
Intervention Type
Drug
Intervention Name(s)
ARA-C
Intervention Description
In high risk patients, consolidation with ara-C in cycles 1 and 3.
Primary Outcome Measure Information:
Title
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
Title
To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival.
Time Frame
1 year
Title
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
Title
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
Secondary Outcome Measure Information:
Title
To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
San Miguel Miguel Angel, Dr
Organizational Affiliation
HOSPITAL LA FE VALENCIA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vellenga Edo, Dr
Organizational Affiliation
Stichting Hemato-Oncologie voor Volwassenen Nederland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lowenberg Bob, Dr
Organizational Affiliation
Stichting Hemato-Oncologie voor Volwassenen Nederland
Official's Role
Study Director
Facility Information:
Facility Name
PALG
City
Lodz
Country
Poland
Facility Name
Hospital General
City
Albacete
Country
Spain
Facility Name
Hospital general
City
Alicante
Country
Spain
Facility Name
Hospital germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
Country
Spain
Facility Name
Institut Català d'Oncologái
City
Barcelona
Country
Spain
Facility Name
Basurtuko Ospitalea
City
Bilbao
Country
Spain
Facility Name
Hospital general
City
Castellon
Country
Spain
Facility Name
Hospital de Fuenlabrada
City
Fuenlabrada
Country
Spain
Facility Name
Hospital "Dr. Trueta"
City
Gerona
Country
Spain
Facility Name
Hospital de Jerez de la Frontera
City
Jerez de la Frontera
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
Hospital Insular de las Palmas
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Complejo Hospitalario León
City
Leon
Country
Spain
Facility Name
Complexo Hospitalario Xeral-Calde
City
Lugo
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Reina Sofia
City
Madrid
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Madrid
Country
Spain
Facility Name
Hospital Severo Ochoa
City
Madrid
Country
Spain
Facility Name
Hospital Sta. Maria del Rosell
City
Murcia
Country
Spain
Facility Name
H. Carlos Haya
City
Málaga
Country
Spain
Facility Name
H. Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Dr Negrín
City
Palma de Gran Canaria
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital de Montecelo
City
Pontevedra
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Salamanca
Country
Spain
Facility Name
Hospital de Cruces
City
Santander
Country
Spain
Facility Name
Hospital de Santiago de Compostela
City
Santiago de Compostela
Country
Spain
Facility Name
H.U. Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
Country
Spain
Facility Name
Hospital general
City
Valencia
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Clínico de Valladolid
City
Valladolid
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
Country
Spain
Facility Name
Hospital Virgen de la Concha
City
Zamora
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Hospital Maciel
City
Montevideo
Country
Uruguay
12. IPD Sharing Statement
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Results Reference
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Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology
URL
http://www.hovon.nl
Description
Hovon Data Center
Learn more about this trial
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
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