All-trans Retinoic Acid, and Arsenic +/- Idarubicin

Completed · Phase 2

Conditions studied: Acute Promyelocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00413166

Run by

M.D. Anderson Cancer Center

People needed

78

Starts

2006-12-01

Expected to finish

2016-02-01

Last updated by the study team

2019-05-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• First trimester of pregnancy (ATRA is teratogenic)
• Corrected QT (QTC) interval must not be greater than 480 milliseconds.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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