---
title: Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL
nct_id: NCT05497310
overall_status: UNKNOWN
phase: PHASE1, PHASE2
sponsor: Hospital Universitario Dr. Jose E. Gonzalez
study_type: INTERVENTIONAL
primary_condition: Promyelocytic Leukemia
countries: Mexico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05497310.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05497310"
ct_last_update_post_date: 2022-10-26
last_seen_at: "2026-05-12T06:07:52.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL

**Official Title:** 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

**NCT ID:** [NCT05497310](https://clinicaltrials.gov/study/NCT05497310)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** Hospital Universitario Dr. Jose E. Gonzalez
- **Conditions:** Promyelocytic Leukemia
- **Start Date:** 2022-07-01
- **Completion Date:** 2025-07-31
- **CT.gov Last Update:** 2022-10-26

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **Induction with attenuated ATO plus low-dose ATRA** (EXPERIMENTAL) — 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).

## Interventions

- **Arsenic trioxide** (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** (DRUG) — Patients will receive ATRA 25/mg/m2/day for 28 continuous days without interruption.

## Primary Outcomes

- **Incidence of Treatment-Emergent Adverse Events** _(time frame: 28 days)_ — Safety will be defined by the number of patients deceased after 1 induction cycle of 28 days

## Secondary Outcomes

- **Overall response** _(time frame: 28 days)_
- **Progression-free survival** _(time frame: 6 months)_
- **Event-free survival** _(time frame: 6 months)_
- **Rate of treatment discontinuation due to toxicity.** _(time frame: 28 days)_

## Locations (1)

- Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer, Monterrey, Nuevo León, Mexico — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hopsital universitario dr. jose e. gonzalez, centro universitario contra el cancer|monterrey|nuevo león|mexico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05497310.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05497310*  
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