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).
N/A
75 Years
Both
Acute Promyelocytic Leukemia
Trial Information
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).
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
San Miguel Miguel Angel, Dr
Investigator Role:
Study Chair
Investigator Affiliation:
HOSPITAL LA FE VALENCIA
Authority:
Spain: Ministry of Health
Study ID:
LPA 2005
NCT ID:
NCT00408278
Start Date:
July 2005
Completion Date:
December 2013
Related Keywords:
- Acute Promyelocytic Leukemia
- Acute Promyelocytic Leukemia
- Leukemia
- Leukemia, Promyelocytic, Acute
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