Status:
COMPLETED
Treatment of Acute Promyelocytic Leukemia With All-Trans Retinoic Acid (ATRA) and Idarubicin (AIDA)
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy of all-trans retinoic acid (ATRA) and idarubicin (AIDA) with a dose reduction in patients older than 70 years of age in the remission induction of...
Detailed Description
Induction chemotherapy: All-trans retinoic acid, will be administered by mouth (PO) from the first day at a dose of 45 mg/m²/day, fractionated into 2 doses. In patients aged \< 20 years, the ATRA do...
Eligibility Criteria
Inclusion
- Age \<= 75 years
- ECOG = 3.
- Morphological diagnosis of M3 or M3v. Those cases without typical morphology but with PML-RARa rearrangement may also be included.
- Genetic diagnosis: t(15;17), PML-RARa rearrangement, monoclonal anti-PML positive. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. The presence of secondary cytogenetic changes associated with t(15;17) is not a reason for exclusion nor do they require a different therapeutic approach.
Exclusion
- Age \> 75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately)
- Absence of PML-RARa rearrangement.
- Prior antileukemic chemotherapy.
- Presence of an associated neoplasm.
- Presence of a severe psychiatric disease.
- HIV seropositivity.
- Contraindication for intensive chemotherapy, especially to anthracyclines.
- Serum creatinine = 2.5 mg/dL.
- Bilirubin, alkaline phosphatase, or SGOT \> 3 times the upper normal limit
- Positive pregnancy test.
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00465933
Start Date
March 1 1999
End Date
November 1 2007
Last Update
March 31 2008
Active Locations (2)
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1
Hospital La Fe de Valencia
Valencia, Valencia, Spain
2
Basurtuko Ospitalea
Basurto, Spain