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Trial Title:
Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL
NCT ID:
NCT05497310
Condition:
Promyelocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Promyelocytic, Acute
Tretinoin
Arsenic Trioxide
Conditions: Keywords:
all-trans retinoic acid
arsenic trioxide
frontline therapy
induction chemotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A consecutive sample of 15 patients with newly diagnosed or relapsed APL who have not
been previously treated with ATO will be prospectively included in this study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
This is an Open label study
Intervention:
Intervention type:
Drug
Intervention name:
Arsenic trioxide
Description:
Patients will receive 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).
Arm group label:
Induction with attenuated ATO plus low-dose ATRA
Other name:
Trisenox
Intervention type:
Drug
Intervention name:
all-trans retinoic acid
Description:
Patients will receive ATRA 25/mg/m2/day for 28 continuous days without interruption.
Arm group label:
Induction with attenuated ATO plus low-dose ATRA
Other name:
Vesanoid
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.
Detailed description:
The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic
plasma concentrations sufficient to achieve therapeutic efficacy with doses of
25mg/m2/day. ATO alone demonstrated considerable effectiveness in this disease. More
recently, an attenuated regimen has been proven to be effective in inducing similar
remission rates and achieving prolonged survival, also demonstrating a reduction in
associated toxicities, mainly hepatic and cardiac when using this new scheme.
The investigators will conduct a phase 1/2, non-randomized, single center,
non-comparative clinical trial to demonstrate the effectiveness of combined therapy of
low-dose ATRA plus attenuated dose ATO which is accessible to a population with limited
resources while maintaining acceptable efficacy and safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Poor functional status (ECOG>2)
- Organic dysfunction (Marshall score ≥2)
- Pregnancy
- Heart failure (NYHA III or IV)
- Renal failure (GFR <30 ml/min/1.72m2)
- History of ventricular arrhythmias or uncontrolled arrhythmias
- Acute myocardial infarction, unstable angina, or stable angina in the last six
months
- Uncontrolled active infection
- Liver disease (Child-Pugh C)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
Address:
City:
Monterrey
Zip:
64460
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
David Gomez-Almaguer, MD
Phone:
+52 81 8348-8510
Email:
dgomezalmaguer@gmail.com
Contact backup:
Last name:
Andres Gomez, MD
Phone:
818470002
Email:
drgomezdeleon@gmail.com
Investigator:
Last name:
Andrés Gómez de León, MD
Email:
Principal Investigator
Investigator:
Last name:
Edgar Coronado-Alejandro, MD
Email:
Sub-Investigator
Start date:
July 1, 2022
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Hospital Universitario Dr. Jose E. Gonzalez
Agency class:
Other
Source:
Hospital Universitario Dr. Jose E. Gonzalez
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05497310
