Phase 3 Study of QTX-2101 for Acute Promyelocytic Leukemia
This Phase 3 study is testing a new oral capsule, QTX-2101, combined with ATRA (all-trans retinoic acid), for adults with newly diagnosed low-risk acute promyelocytic leukemia (APL). APL is a type of fast-growing blood cancer. Researchers want to see if QTX-2101 + ATRA is as effective and safe as the standard treatment, which is IV arsenic trioxide (ATO) + ATRA. The study will look at how much QTX-2101 is in the blood and if participants achieve molecular complete remission (meaning no signs of cancer cells). You may be able to join if you are 18 to 70 years old and have a confirmed diagnosis of low- or intermediate-risk APL. The current status of this study is unclear.
- Study design
- This is an open-label Phase 3 study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 150 participants.
- What's involved
- During the induction phase, you would receive QTX-2101 + ATRA or IV ATO + ATRA daily for up to 60 days. During the consolidation phase, QTX-2101 or IV ATO is given daily according to your doctor's plan.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure molecular complete remission for up to 60 days of induction and three 8-week cycles of consolidation treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
At a glance
Conditions
NCT07504458
Where you'd take part
This study runs at 26 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Quetzal Site 1
Duarte, Californiastudy coordinator listed
Recruiting
Quetzal Site 10
Cáceres, Spainstudy coordinator listed
Recruiting
Quetzal Site 11
Palma de Mallorca, Balearic Islands, Spainstudy coordinator listed
Recruiting
Quetzal Site 12
Nashville, Tennesseestudy coordinator listed
Recruiting
Quetzal Site 13
Augusta, Georgiastudy coordinator listed
Recruiting
Quetzal Site 14
Paris, Francestudy coordinator listed
Recruiting
Quetzal Site 15
Barcelona, Spainstudy coordinator listed
Recruiting
Quetzal Site 16
Birmingham, Alabamastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Maximum observed plasma (concentration (Cmax) of QTX-2101 for ASIIIUp to 1 cycle of consolidation therapy (each cycle is 8 weeks)
Cmax is defined as the maximum observed plasma concentration following administration of \[investigational product\], determined from plasma concentration-time data.
- Molecular complete remission (molecular CR) rateUp to 60 days of induction and 3 8-week cycles of consolidation treatment
mCR is defined as the absence of detectable PML-RARA fusion transcript in bone marrow assessed by a validated quantitative reverse transcription polymerase chain reaction (RT-qPCR) assay .The mCR rate is defined as the proportion of participants achieving molecular remission at the specified assessment time point following induction and consolidation therapy.