To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?