Effectiveness and Safety of Therapy Based on Attenuated Arsenic Trioxide Plus Low Doses of All-trans Retinoic Acid as Remission Induction Therapy in Patients With Acute Promyelocytic Leukemia Phase 1/2 Clinical Trial
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
ATRA is the standard of care for all patients with APL. The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective. In this study we intent to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \>18 years
• Both genders
• new diagnosis of APL
• Diagnosis of relapsed APL who have not been previously treated with ATO
• Morphological diagnosis of APL confirmed by PCR or FISH
Locations
Other Locations
Mexico
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
RECRUITING
Monterrey
Contact Information
Primary
Edgar Coronado-Alejandro, MD
edgar.coronado.al@gmail.com
8441077402
Backup
Andrés Gómez de León, MD
drgomezdeleon@gmail.com
818470002
Time Frame
Start Date: 2022-07-01
Completion Date: 2025-07-31
Participants
Target number of participants: 15
Treatments
Experimental: Induction with attenuated ATO plus low-dose ATRA
Remission induction therapy will be administrated as ATRA 25/mg/m2/day for 28 continuous days without interruption if APL is suspected. ATO 0.3mg/kg/day for days 1-5 (5 doses) and then 0.25 mg/kg/day every other day twice a week for the next 3 weeks (6 doses).
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario Dr. Jose E. Gonzalez