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

Phase 1

Recruiting

• Conditions: Promyelocytic Leukemia
• Interventions: Drug: Arsenic trioxide; Drug: all-trans retinoic acid

• Registration Number: NCT05497310
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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 effective...

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 achievi...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction with attenuated ATO plus low-dose ATRA	Arsenic trioxide	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).
Induction with attenuated ATO plus low-dose ATRA	all-trans retinoic acid	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).

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	28 days	Safety will be defined by the number of patients deceased after 1 induction cycle of 28 days

Secondary Outcome Measures

Name	Time	Method
Overall response	28 days	Overall response rate was definide as partial response plus complete response after 1
Progression-free survival	6 months	Time from achievement of complete hematologic remission to relapse
Event-free survival	6 months	Time from registration to induction failure, relapse, or death.
Rate of treatment discontinuation due to toxicity.	28 days	Rate of treatment discontinuation due to toxicity.

Trial Locations

Locations (1)

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer; 🇲🇽 Monterrey, Nuevo Leon, Mexico