Status:
COMPLETED
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE4
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 mit...
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 day...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00408278
Start Date
July 1 2005
End Date
December 1 2013
Last Update
October 28 2014
Active Locations (42)
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1
PALG
Lodz, Poland
2
Hospital Juan Canalejo
A Coruña, Spain
3
Hospital General
Albacete, Spain
4
Hospital general
Alicante, Spain