Status:
UNKNOWN
Acute Promyelocytic Leukemia 2006 (APL)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Leukemia, Promyelocytic, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
Definition: Extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied. APL is a specific type of acute myeloid leukemia (AML) ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00378365
Start Date
October 1 2006
End Date
September 1 2016
Last Update
April 16 2014
Active Locations (1)
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1
Chu Avicenne
Bobigny, France, 93000