NCT06982274 Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
| NCT ID | NCT06982274 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Condition | Acute Promyelocytic Leukemia (APL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 115 participants in total. It began in 2023-10-20 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is a non-randomized, multicenter, prospective study, aiming to treat patients with newly diagnosed acute promyelocytic leukemia with a combination of oral arsenic and atra, with low dose chemotherapy for those with high-risk disease (white blood cell count above 10x10a9/L). The primary objective is to assess the 2-year overall survival (OS) in these patients, comparing with the historical control group of patients treated with ATRA/chemotherapy according to the IC-APL 2006 protocol.
Eligibility Criteria
Inclusion Criteria: * Informed consent * New diagnosis of APL by cytomorphology, confirmed for molecular analysis * Age ≥18 and ≤75 years * Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l) * Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l) * Women must meet at least one of the following criteria to be eligible for inclusion in the study: Postmenopausal (12 months of amenorrhea or 6 months of amenorrhea with serum FSH \> 40 U/ml); After undergoing hysterectomy or bilateral oophorectomy; Continuous and correct use of a contraceptive method with a Pearl Index \<1% (e.g., implants, oral contraceptives, intrauterine devices); Sexual abstinence; Vasectomy of sexual partner. Exclusion Criteria: * High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician; * Age \<18 or \>75 years * Other active malignancy at the time of study entry * Lack of diagnostic confirmation at the genetic level * Significant arrhythmias, ECG abnormalities, or neuropathy: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (\<50 beats per minute); QTc \> 500 ms on ECG screening for both sexes; Right bundle branch block with left anterior hemiblock or bifascicular block * High-risk patients with other cardiac contraindications for intensive chemotherapy (LVEF \< 50%) * Uncontrolled and potentially fatal infections * Severe uncontrolled pulmonary or cardiac disease * Severe hepatic or renal dysfunction * Known HIV and/or hepatitis C infection * Pregnant or breastfeeding women * Allergy to the study drug or excipients in the study medication * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or the assessment of study outcomes * Use of other investigational drugs at the time of enrollment or within 30 days before study entry.
Contact & Investigator
Eduardo M Rego, MD PhD
PRINCIPAL INVESTIGATOR
Instituto do Cancer do Estado de Sao Paulo
Frequently Asked Questions
Who can join the NCT06982274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Promyelocytic Leukemia (APL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06982274 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06982274 currently recruiting?
Yes, NCT06982274 is actively recruiting participants. Contact the research team at elaine.uuehara@hc.fm.usp.br for enrollment information.
Where is the NCT06982274 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06982274 clinical trial?
NCT06982274 is sponsored by Instituto do Cancer do Estado de São Paulo. The principal investigator is Eduardo M Rego, MD PhD at Instituto do Cancer do Estado de Sao Paulo. The trial plans to enroll 115 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.