Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Promyelocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an Open label study

Study Groups

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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).

Group Type EXPERIMENTAL

Arsenic trioxide

Intervention Type DRUG

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).

all-trans retinoic acid

Intervention Type DRUG

Patients will receive ATRA 25/mg/m2/day for 28 continuous days without interruption.

Interventions

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Arsenic trioxide

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).

Intervention Type DRUG

all-trans retinoic acid

Patients will receive ATRA 25/mg/m2/day for 28 continuous days without interruption.

Intervention Type DRUG

Other Intervention Names

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Trisenox Vesanoid

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No