Acute Promyelocytic Leukemia 2006 (APL)

This study is currently recruiting participants.
Verified March 2007 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00378365
First received: September 18, 2006
Last updated: April 15, 2014
Last verified: March 2007
  Purpose

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 Intervention Phase
Leukemia, Promyelocytic, Acute
Procedure: Arsenic trioxide
Procedure: ATRA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    For Patients aged 70 years or less with WBC<10.000/mm3, The primary end point

  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • For Patients aged 70 years or less with WBC<10.000/mm3 : [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    For Patients aged 70 years or less with WBC<10.000/mm3 :

  • Relapse (molecular or hematological). [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Relapse (molecular or hematological).

  • Kinetics of decrease of PML-RARA transcript level during and after consolidation course. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Kinetics of decrease of PML-RARA transcript level during and after consolidation course.

  • Survival at 2 years. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Survival at 2 years.

  • Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment. [ Time Frame: during th study ] [ Designated as safety issue: Yes ]
    Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment.

  • Days on antibiotics, transfusion requirement and nights spent in Hospital [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Days on antibiotics, transfusion requirement and nights spent in Hospital

  • For Patients aged 70 years or less with WBC>10.000/mm3 [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    For Patients aged 70 years or less with WBC>10.000/mm3

  • event free survival at 2 years from CR achievement [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    event free survival at 2 years from CR achievement

  • Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment.

  • For Patients older than 70 years with WBC<10.000 /mm3 [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    For Patients older than 70 years with WBC<10.000 /mm3

  • Kinetics of decrease of PML-RARA transcript level during and after consolidation course. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Kinetics of decrease of PML-RARA transcript level during and after

  • Relapse and survival at 2 years. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Relapse and survival at 2 years.

  • Side effects of the treatment, including mortality and morbidity of consolidation treatment. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Side effects of the treatment, including mortality and morbidity of

  • For patients older than 70 years with WBC>10.000 /mm3 [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    For patients older than 70 years with WBC>10.000 /mm3


Estimated Enrollment: 800
Study Start Date: October 2006
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arsenic trioxide
Procedure: Arsenic trioxide
Arsenic trioxide
Other Name: Arsenic trioxide
Procedure: ATRA
ATRA
Other Name: ATRA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00378365     History of Changes
Other Study ID Numbers: P050604
Study First Received: September 18, 2006
Last Updated: April 15, 2014
Health Authority: France: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014