Acute Promyelocytic Leukemia 2006 (APL) - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00378365

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 III

MedlinePlus related topics: Arsenic Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Arsenic trioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	A Randomized Trial Assessing the Role of Arsenic Trioxide and/or ATRA During Consolidation Course in Newly Diagnosed Acute Promyelocytic Leukemia (APL)

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
For Patients aged 70 years or less with WBC>10.000/mm3, The primary end point will be the Relapse (molecular or hematological).
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

Secondary Outcome Measures:

For Patients aged 70 years or less with WBC<10.000/mm3 :
Relapse (molecular or hematological).
Kinetics of decrease of PML-RARA transcript level during and after consolidation course.
Survival at 2 years.
Side effects of the treatment, including treatment-related mortality and morbidity of consolidation treatment.
Days on antibiotics, transfusion requirement and nights spent in Hospital
For Patients aged 70 years or less with WBC>10.000/mm3
event free survival at 2 years from CR achievement
For Patients older than 70 years with WBC<10.000 /mm3
Relapse and survival at 2 years.
Side effects of the treatment, including mortality and morbidity of consolidation treatment.
For patients older than 70 years with WBC>10.000 /mm3

Estimated Enrollment:	800
Study Start Date:	October 2006
Estimated Study Completion Date:	September 2013

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

Study ID Numbers:	P050604
Study First Received:	September 18, 2006
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00378365 History of Changes
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

Study placed in the following topic categories:

Leukemia
Idarubicin
Leukemia, Promyelocytic, Acute
Arsenic trioxide

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute Promyelocytic Leukemia

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses

Leukemia, Promyelocytic, Acute
Arsenic trioxide
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009