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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
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Study Description
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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
Acute Promyelocytic Leukemia Drug: ATRA Drug: Idarubicina Drug: Mitoxantrone Drug: ARA-C 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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Intervention Details:
  • 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.

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

Secondary Outcome Measures :
  1. To compare all outcomes with those achieved with the PETHEMA LPA99 protocol. [ Time Frame: 2 years ]

Eligibility Criteria
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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
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
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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


Locations
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Sponsors and Collaborators
PETHEMA Foundation
Investigators
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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
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by PETHEMA Foundation:
Acute Promyelocytic Leukemia
Additional relevant MeSH terms:
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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