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

October 24, 2022 updated by: David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Recruiting
        • Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrés Gómez de León, MD
        • Sub-Investigator:
          • Edgar Coronado-Alejandro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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).
Other Names:
  • Trisenox
Drug: all-trans retinoic acid
Patients will receive ATRA 25/mg/m2/day for 28 continuous days without interruption.
Other Names:
  • Vesanoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

July 31, 2025

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE22-00019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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