NCT00378365

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 16, 2014

Status Verified

March 1, 2007

Enrollment Period

9.9 years

First QC Date

September 18, 2006

Last Update Submit

April 15, 2014

Conditions

Leukemia, Promyelocytic, Acute

Keywords

Acute promyelocytic leukaemiaATRAIdarubicinArsenic trioxidePatient with a newly acute promyelocytic leukaemia (APL)Unmapped MeSH term

Outcome Measures

Primary Outcomes (2)

  • 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

    For Patients aged 70 years or less with WBC\<10.000/mm3, The primary end point

    during de study

  • For patients older than 70 years with WBC>10.000 /mm3, The primary end point will be EFS at 2 years from diagnosis

    For patients older than 70 years with WBC\>10.000 /mm3, The primary end point will be EFS at 2 years from diagnosis

    during the study

Secondary Outcomes (14)

  • For Patients aged 70 years or less with WBC<10.000/mm3 :

    during the study

  • Relapse (molecular or hematological).

    during the study

  • Kinetics of decrease of PML-RARA transcript level during and after consolidation course.

    during the study

  • Survival at 2 years.

    during the study

  • Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment.

    during th study

  • +9 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Arsenic trioxide

Procedure: Arsenic trioxideProcedure: ATRA

Interventions

Arsenic trioxidePROCEDURE

Arsenic trioxide

1
ATRAPROCEDURE

ATRA

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Avicenne

Bobigny, 93000, France

RECRUITING

Related Publications (1)

  • Ades L, Thomas X, Bresler AG, Raffoux E, Spertini O, Vey N, Marchand T, Recher C, Pigneux A, Girault S, Deconinck E, Gardin C, Tournilhac O, Lambert JF, Chevallier P, de Botton S, Lejeune J, Dombret H, Chevret S, Fenaux P. Arsenic trioxide is required in the treatment of newly diagnosed acute promyelocytic leukemia. Analysis of a randomized trial (APL 2006) by the French Belgian Swiss APL group. Haematologica. 2018 Dec;103(12):2033-2039. doi: 10.3324/haematol.2018.198614. Epub 2018 Jul 19.

    PMID: 30026341DERIVED

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Lionel ADES, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionel ADES, MD

CONTACT

+33(0)-148 95 70 55Lionel.ades@avc.aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 20, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 16, 2014

Record last verified: 2007-03

Locations

FR(1)