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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Arsenic Trioxide; Gemtuzumab; Idarubicin; Tretinoin

Criteria

Inclusion Criteria:

1. A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by cytogenetics, PCR, or POD test.

2. Provision of written informed consent.

3. Patients in whom therapy for APL was initiated on an emergent basis are eligible

Exclusion Criteria:

1. First trimester of pregnancy (ATRA is teratogenic)

2. Corrected QT (QTC) interval must not be greater than 480 milliseconds.