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Acute Promyelocytic Leukemia 2006 (APL)

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ClinicalTrials.gov Identifier: NCT00378365
Recruitment Status : Unknown
Verified March 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 20, 2006
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
To assess the role of Arsenic trioxide and/or ATRA during consolidation course in APL. It is hoped that the investigational arms will further increase the event-free survival at 2 years, with reduced toxicity and without increasing the relapse rate by comparison with a classical anthracycline-AraC consolidation regimen.

Condition or disease Intervention/treatment Phase
Leukemia, Promyelocytic, Acute Procedure: Arsenic trioxide Procedure: ATRA Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Assessing the Role of Arsenic Trioxide and/or ATRA During Consolidation Course in Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Study Start Date : October 2006
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: 1
Arsenic trioxide
Procedure: Arsenic trioxide
Arsenic trioxide
Procedure: ATRA
ATRA



Primary Outcome Measures :
  1. For Patients aged 70 years or less with WBC<10.000/mm3, The primary end point will be event free survival at 2 years from CR achievement [ Time Frame: during de study ]
    For Patients aged 70 years or less with WBC<10.000/mm3, The primary end point

  2. For patients older than 70 years with WBC>10.000 /mm3, The primary end point will be EFS at 2 years from diagnosis [ Time Frame: during the study ]
    For patients older than 70 years with WBC>10.000 /mm3, The primary end point will be EFS at 2 years from diagnosis


Secondary Outcome Measures :
  1. For Patients aged 70 years or less with WBC<10.000/mm3 : [ Time Frame: during the study ]
    For Patients aged 70 years or less with WBC<10.000/mm3 :

  2. Relapse (molecular or hematological). [ Time Frame: during the study ]
    Relapse (molecular or hematological).

  3. Kinetics of decrease of PML-RARA transcript level during and after consolidation course. [ Time Frame: during the study ]
    Kinetics of decrease of PML-RARA transcript level during and after consolidation course.

  4. Survival at 2 years. [ Time Frame: during the study ]
    Survival at 2 years.

  5. Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment. [ Time Frame: during th study ]
    Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment.

  6. Days on antibiotics, transfusion requirement and nights spent in Hospital [ Time Frame: during the study ]
    Days on antibiotics, transfusion requirement and nights spent in Hospital

  7. For Patients aged 70 years or less with WBC>10.000/mm3 [ Time Frame: during the study ]
    For Patients aged 70 years or less with WBC>10.000/mm3

  8. event free survival at 2 years from CR achievement [ Time Frame: during the study ]
    event free survival at 2 years from CR achievement

  9. Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment. [ Time Frame: during the study ]
    Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment.

  10. For Patients older than 70 years with WBC<10.000 /mm3 [ Time Frame: during the study ]
    For Patients older than 70 years with WBC<10.000 /mm3

  11. Kinetics of decrease of PML-RARA transcript level during and after consolidation course. [ Time Frame: during the study ]
    Kinetics of decrease of PML-RARA transcript level during and after

  12. Relapse and survival at 2 years. [ Time Frame: during the study ]
    Relapse and survival at 2 years.

  13. Side effects of the treatment, including mortality and morbidity of consolidation treatment. [ Time Frame: during the study ]
    Side effects of the treatment, including mortality and morbidity of

  14. For patients older than 70 years with WBC>10.000 /mm3 [ Time Frame: during the study ]
    For patients older than 70 years with WBC>10.000 /mm3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of APL based on morphological grounds, which will have to be confirmed by the presence of t(15;17) and/or PML-RARA rearrangement with characterization of the bcr subtype (PML-RAR characterization).
  • Untreated patients.
  • No contraindication to intensive chemotherapy (especially well documented cardiac contraindication to idarubicin).
  • In female patients: absence of pregnancy and adequate contraceptive methods (due to teratogenetic effects of ATRA in early pregnancy).
  • Absence of Hypersensitivity to Arsenic derivatives.
  • No QT interval prolongation or complete atria-ventricular block.
  • Written informed consent.

Exclusion Criteria:

  • Patients already treated.
  • Patients with contraindication to intensive chemotherapy, especially well documented cardiac contraindication to Idarubicin.
  • In female patients: pregnancy or absence of adequate contraceptive Methods
  • QT interval prolongation or complete atria-ventricular block.
  • Hypersensitivity to Arsenic derivatives.

Information from the National Library of Medicine

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): NCT00378365


Contacts
Contact: Lionel ADES, MD +33(0)-148 95 70 55 Lionel.ades@avc.aphp.fr

Locations
France
Chu Avicenne Recruiting
Bobigny, France, 93000
Contact: Lionel ADES, MD,PhD    +33(0)- 148 95 70 55    Lionel.ades@avc.aphp.fr   
Principal Investigator: Lionel ADES, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Lionel ADES, MD,PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00378365     History of Changes
Other Study ID Numbers: P050604
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute promyelocytic leukaemia
ATRA
Idarubicin
Arsenic trioxide
Patient with a newly acute promyelocytic leukaemia (APL)
Unmapped MeSH term

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic trioxide
Antineoplastic Agents