Acute Promyelocytic Leukemia 2006 (APL)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Arsenic trioxide
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014