drugset / Trial / NCT03848754
Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a prospective, single-center phase 1 clinical study aimed at determining the maximum-tolerated dose and safety of the combination of gemtuzumab ozogamicin (GO) and pracinostat (P) in patients with relapsed/refractory acute myeloid leukemia.
Timeline
- Start
- 2019-05-24
- Primary completion
- 2021-05-05
- Completion
- 2021-05-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | 2 mg/m2 | Intravenous |
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | 3 mg/m2 | Intravenous |
| Subject | Pracinostat | Other / unclassified | 45 mg | Oral |
| Subject | Pracinostat | Other / unclassified | 60 mg | Oral |