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

Sponsor
PETHEMA Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT00408278
Collaborator
(none)
300
42
101
7.1
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Dec 1, 2013

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival. [1 year]

  3. 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]

  4. 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

  1. To compare all outcomes with those achieved with the PETHEMA LPA99 protocol. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PALG Lodz Poland
2 Hospital General Albacete Spain
3 Hospital general Alicante Spain
4 Hospital germans Trias i Pujol Badalona Spain
5 Hospital Clinic Barcelona Spain
6 Hospital de Sant Pau Barcelona Spain
7 Institut Català d'Oncologái Barcelona Spain
8 Basurtuko Ospitalea Bilbao Spain
9 Hospital general Castellon Spain
10 Hospital de Fuenlabrada Fuenlabrada Spain
11 Hospital "Dr. Trueta" Gerona Spain
12 Hospital de Jerez de la Frontera Jerez de la Frontera Spain
13 Hospital Juan Canalejo La Coruña Spain
14 Hospital Insular de las Palmas Las Palmas de Gran Canaria Spain
15 Complejo Hospitalario León Leon Spain
16 Complexo Hospitalario Xeral-Calde Lugo Spain
17 Hospital 12 de Octubre Madrid Spain
18 Hospital Clínico San Carlos Madrid Spain
19 Hospital Puerta de Hierro Madrid Spain
20 Hospital Reina Sofia Madrid Spain
21 Hospital San Pedro de Alcántara Madrid Spain
22 Hospital Severo Ochoa Madrid Spain
23 Hospital Sta. Maria del Rosell Murcia Spain
24 H. Carlos Haya Málaga Spain
25 H. Universitario Virgen de la Victoria Málaga Spain
26 Hospital Central de Asturias Oviedo Spain
27 Hospital Dr Negrín Palma de Gran Canaria Spain
28 Hospital de Navarra Pamplona Spain
29 Hospital de Montecelo Pontevedra Spain
30 Hospital Clínico Universitario Salamanca Spain
31 Hospital de Cruces Santander Spain
32 Hospital de Santiago de Compostela Santiago de Compostela Spain
33 H.U. Virgen del Rocio Sevilla Spain
34 Hospital Joan XXIII Tarragona Spain
35 Hospital Dr. Peset Valencia Spain
36 Hospital general Valencia Spain
37 Hospital La Fe Valencia Spain
38 Hospital Clínico de Valladolid Valladolid Spain
39 Hospital Txagorritxu Vitoria Spain
40 Hospital Virgen de la Concha Zamora Spain
41 Hospital Clínico Universitario Lozano Blesa Zaragoza Spain
42 Hospital Maciel Montevideo Uruguay

Sponsors and Collaborators

  • PETHEMA Foundation

Investigators

  • Study Chair: San Miguel Miguel Angel, Dr, HOSPITAL LA FE VALENCIA
  • Study Director: Vellenga Edo, Dr, Stichting Hemato-Oncologie voor Volwassenen Nederland
  • Study Director: Lowenberg Bob, Dr, Stichting Hemato-Oncologie voor Volwassenen Nederland

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00408278
Other Study ID Numbers:
  • LPA 2005
First Posted:
Dec 6, 2006
Last Update Posted:
Oct 28, 2014
Last Verified:
Oct 1, 2014
Keywords provided by PETHEMA Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2014