Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
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ClinicalTrials.gov Identifier: NCT00408278 |
Recruitment Status :
Completed
First Posted : December 6, 2006
Last Update Posted : October 28, 2014
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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 |
---|---|---|
Acute Promyelocytic Leukemia | Drug: ATRA Drug: Idarubicina Drug: Mitoxantrone Drug: ARA-C | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | July 2005 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | December 2013 |

- 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.
- 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 ]
- To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 1 year ]
- To compare all outcomes with those achieved with the PETHEMA LPA99 protocol. [ Time Frame: 2 years ]

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Ages Eligible for Study: | up to 75 Years (Child, Adult, Older Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408278

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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00408278 |
Other Study ID Numbers: |
LPA 2005 |
First Posted: | December 6, 2006 Key Record Dates |
Last Update Posted: | October 28, 2014 |
Last Verified: | October 2014 |
Acute Promyelocytic Leukemia |
Leukemia Leukemia, Promyelocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid, Acute Leukemia, Myeloid Mitoxantrone Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |