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

Phase 4

Completed

• Conditions: Acute Promyelocytic Leukemia

• Registration Number: NCT00408278
• Lead Sponsor: PETHEMA Foundation

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-12-05
• Study First Submitted QC: 2006-12-05
• Study First Posted: 2006-12-06
• Primary Completion: 2012-04
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.	1 year
To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival.	1 year
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	1 year
To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.	1 year

Secondary Outcome Measures

Name	Time	Method
To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.	2 years

Trial Locations

Locations (40)

PALG; 🇵🇱 Lodz, Poland

Hospital General; 🇪🇸 Albacete, Spain

Hospital general; 🇪🇸 Valencia, 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 de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain

Hospital "Dr. Trueta"; 🇪🇸 Gerona, Spain

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