Status:
COMPLETED
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.
Detailed Description
All-trans retinoic acid (ATRA) and ATO are designed to cause the APL cells to mature and function normally. Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells...
Eligibility Criteria
Inclusion
- A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by cytogenetics, PCR, or POD test.
- Provision of written informed consent.
- Patients in whom therapy for APL was initiated on an emergent basis are eligible
Exclusion
- First trimester of pregnancy (ATRA is teratogenic)
- Corrected QT (QTC) interval must not be greater than 480 milliseconds.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00413166
Start Date
December 1 2006
End Date
February 1 2016
Last Update
May 7 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030