Combined therapy of low-dose ATRA and attenuated ATO for promyelocytic leukemia
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
This study is testing a new treatment using low doses of two medications for adults with acute promyelocytic leukemia to see if it can help them without causing too many side effects.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Locations | 1 site (Monterrey, Nuevo Leon) |
| Trial ID | NCT05497310 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of a combined therapy using low-dose all-trans retinoic acid (ATRA) and attenuated arsenic trioxide (ATO) in patients with acute promyelocytic leukemia (APL). The study will include adults with newly diagnosed or relapsed APL who have not previously received ATO treatment. By utilizing lower doses of ATRA and ATO, the trial seeks to maintain therapeutic efficacy while reducing associated toxicities. The trial is designed as a phase 1/2, non-randomized, single-center study to assess the outcomes of this treatment regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a new diagnosis of APL or relapsed APL who have not been previously treated with ATO.
Not a fit: Patients with poor functional status, significant organ dysfunction, or recent cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a safer and effective treatment option for patients with APL, particularly those with limited resources.
How similar studies have performed: Other studies have shown promising results with similar low-dose regimens in APL, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Monterrey, Nuevo Leon
- Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer — Monterrey, Nuevo Leon, Mexico (Recruiting)
Study contacts
- Study coordinator: Edgar Coronado-Alejandro, MD
- Email: edgar.coronado.al@gmail.com
- Phone: 8441077402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.