BridgeMD
New treatment option for Acute Promyelocytic Leukemia (APL)
Official title Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
ClinicalTrials.gov ID: NCT06982274
What this study is testing
What is Realgar-Indigo Naturalis Formulation?
Realgar-Indigo Naturalis Formulation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute promyelocytic leukemia (apl).
Also referred to as Oral Arsenic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)
You likely can't join if
- High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician;
- Age \ 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...
- High-risk patients with other cardiac contraindications for intensive chemotherapy (LVEF \< 50%)
See the full eligibility 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...
- High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician;
- Age \ 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 (\ 500 ms on...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.