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).
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
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
Secondary Outcome
To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.
Condition
Acute Promyelocytic Leukemia
Intervention
ATRA
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
300
Start Date
July 2005
Completion Date
December 2013
Primary Completion Date
April 2012
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.
Gender
All
Ages
N/A - 75 Years
Accepts Healthy Volunteers
No
Contacts
San Miguel Miguel Angel, Dr, ,
Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT00408278
Organization ID
LPA 2005
Responsible Party
Sponsor
Study Sponsor
PETHEMA Foundation
Study Sponsor
San Miguel Miguel Angel, Dr, Study Chair, HOSPITAL LA FE VALENCIA
Verification Date
October 2014