BridgeMD
New treatment option for Acute Promyelocytic Leukemia (APL)
Official title Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
ClinicalTrials.gov ID: NCT07504458
What this study is testing
What is QTX-2101 + ATRA?
QTX-2101 + ATRA is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute promyelocytic leukemia (apl).
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
- This Phase 3 study in adult participants with newly diagnosed low-risk APL will evaluate the efficacy, safety, and PK of an oral capsule formulation of ATO, in combination with ATRA.
- Phase 3: a large, late-stage study
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 71
You may be able to join if
- Informed Consent
- Participants must be between 18 and under 71 years of age
- Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)
- Participants must be classified as low- or intermediate-risk APL
- Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other...
You likely can't join if
- Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG
- Participants who have central nervous system leukemia
- Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make...
- Participants who are pregnant, breastfeeding, or unwilling to use contraception
- Participants who are unable to safely take study medication, including severe neuropathy, inability to swallow oral medication, malabsorption issues...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Stanford, California, United States
- Buffalo, New York, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Palma de Mallorca, Balearic Islands, Spain
- Cáceres, Spain
- Valencia, Spain
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 71 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Stanford, California, United States; Buffalo, New York, United States; The Bronx, New York, United States; Columbus, Ohio, United States and 6 more location(s). 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.