Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
This study is ongoing, but not recruiting participants.
Sponsor:
PETHEMA Foundation
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00408278
First received: December 5, 2006
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Promyelocytic Leukemia |
Drug: ATRA Drug: Idarubicina Drug: Mitoxantrone Drug: ARA-C |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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). |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
familial acute myeloid leukemia with mutated CEBPA
MedlinePlus related topics:
Leukemia
U.S. FDA Resources
Further study details as provided by PETHEMA Foundation:
Primary Outcome Measures:
- To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To compare all outcomes with those achieved with the PETHEMA LPA99 protocol. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: ATRA
45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months
Drug: Idarubicina
Induction: 12 mg/m2 days 2, 4, 6 and 8 Consolidation: 5 mg/m2 days 1-4 in cycle 1 and 12 mg/m2 day 1 in cycle 3.
Drug: Mitoxantrone
Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2
Drug: ARA-C
In high risk patients, consolidation with ara-C in cycles 1 and 3.
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
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408278
Locations
| Poland | |
| PALG | |
| Lodz, Poland | |
| Spain | |
| Hospital General | |
| Albacete, Spain | |
| Hospital general | |
| Alicante, Spain | |
| Hospital germans Trias i Pujol | |
| Badalona, Spain | |
| Hospital Clinic | |
| Barcelona, Spain | |
| Institut Català d'Oncologái | |
| Barcelona, Spain | |
| Hospital de Sant Pau | |
| Barcelona, Spain | |
| Basurtuko Ospitalea | |
| Bilbao, Spain | |
| Hospital general | |
| Castellon, Spain | |
| Hospital de Fuenlabrada | |
| Fuenlabrada, Spain | |
| Hospital "Dr. Trueta" | |
| Gerona, Spain | |
| Hospital de Jerez de la Frontera | |
| Jerez de la Frontera, Spain | |
| Hospital Juan Canalejo | |
| La Coruña, Spain | |
| Hospital Insular de las Palmas | |
| Las Palmas de Gran Canaria, Spain | |
| Complejo Hospitalario León | |
| Leon, Spain | |
| Complexo Hospitalario Xeral-Calde | |
| Lugo, Spain | |
| Hospital Severo Ochoa | |
| Madrid, Spain | |
| Hospital 12 de Octubre | |
| Madrid, Spain | |
| Hospital Clínico San Carlos | |
| Madrid, Spain | |
| Hospital Reina Sofia | |
| Madrid, Spain | |
| Hospital Puerta de Hierro | |
| Madrid, Spain | |
| Hospital San Pedro de Alcántara | |
| Madrid, Spain | |
| Hospital Sta. Maria del Rosell | |
| Murcia, Spain | |
| H. Universitario Virgen de la Victoria | |
| Málaga, Spain | |
| H. Carlos Haya | |
| Málaga, Spain | |
| Hospital Central de Asturias | |
| Oviedo, Spain | |
| Hospital Dr Negrín | |
| Palma de Gran Canaria, Spain | |
| Hospital de Navarra | |
| Pamplona, Spain | |
| Hospital de Montecelo | |
| Pontevedra, Spain | |
| Hospital Clínico Universitario | |
| Salamanca, Spain | |
| Hospital de Cruces | |
| Santander, Spain | |
| Hospital de Santiago de Compostela | |
| Santiago de Compostela, Spain | |
| H.U. Virgen del Rocio | |
| Sevilla, Spain | |
| Hospital Joan XXIII | |
| Tarragona, Spain | |
| Hospital Dr. Peset | |
| Valencia, Spain | |
| Hospital La Fe | |
| Valencia, Spain | |
| Hospital general | |
| Valencia, Spain | |
| Hospital Clínico de Valladolid | |
| Valladolid, Spain | |
| Hospital Txagorritxu | |
| Vitoria, Spain | |
| Hospital Virgen de la Concha | |
| Zamora, Spain | |
| Hospital Clínico Universitario Lozano Blesa | |
| Zaragoza, Spain | |
| Uruguay | |
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | PETHEMA Foundation |
| ClinicalTrials.gov Identifier: | NCT00408278 History of Changes |
| Other Study ID Numbers: | LPA 2005 |
| Study First Received: | December 5, 2006 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by PETHEMA Foundation:
|
Acute Promyelocytic Leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid, Acute Leukemia, Myeloid Cytarabine Mitoxantrone Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013