Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
QTX-2101+ ATRA · 1 trial · 5 indications
Cmax is defined as the maximum observed plasma concentration following administration of \[investigational product\], determined from plasma concentration-time data.
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.
| Arm | Type | Description |
|---|---|---|
| QTX-2101 | EXPERIMENTAL | QTX-2101 (oral arsenic trioxide; ATO) All-trans-retinoic-acid (ATRA; oral) |
| IV ATO | ACTIVE_COMPARATOR | IV Arsenic Trioxide (ATO) All-trans-retinoic-acid (ATRA; oral) |
| Name | Type | Description |
|---|---|---|
| QTX-2101 + ATRA | DRUG | The experimental regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, QTX-2101 is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle. |
| IV arsenic trioxide (ATO) + ATRA | DRUG | The comparator regimen consists of IV ATO administered once daily during induction, given continuously, for up to a maximum of 60 days. During consolidation, IV ATO is administered once daily, per investigator's protocol. ATRA is administered orally in two divided daily doses during induction, given continuously until bone marrow remission (not exceeding 60 days). During consolidation, ATRA is taken orally in two divided daily doses following a 2-weeks-on / 2-weeks-off schedule within each 8-week cycle. |
Inclusion Criteria: 1. Informed Consent 2. Participants must be between 18 and under 71 years of age 3. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA) 4. Participants must be classified as low- or intermediate-risk APL 5. Participants m...