Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04839341 | Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients | PHASE1 | COMPLETED | 12 | — | — | Feb 24, 2021 | Jun 28, 2024 | Jun 27, 2025 | 2 | China |
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Number of participants with an AE.
Number of participants could tolerate the Uproleselan combined with chemotherapy.
| Arm | Type | Description |
|---|---|---|
| A Phase I, open-labeled multicenter study | EXPERIMENTAL | Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) |
| Name | Type | Description |
|---|---|---|
| Uproleselan | DRUG | A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin |
Inclusion Criteria: 1. ≥18 years and ≤60 years in age 2. AML (including secondary AML) diagnosed as per WHO standards (2008). 3. For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied ...