Detail of the clinical trial
| Title of the trial | A Phase 3, Randomized, Controlled, Open-Label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia |
|---|---|
| EudraCT number | 2017-000318-40 |
| Protocol number | Pevonedistat-3001 |
| Sponsor | Takeda Development Center Americas, Inc., 95 Hayden Avenue, Lexington, Massachusetts 02421, United States of America |
| Indications | Hemato-oncology |
| Diagnosis | Acute Myeloid Leukemia; MDS, CMML |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2017 |
| Date of approval by Institute (SÚKL) | 15.12.2017 |
| Date of approval by EC | 2.11.2017 |
| Date of initiation CT in ČR | 4.6.2018 |
| Date of ending CT in ČR | 23.2.2022 |
| Notice | |
| Sites |
Fakultní nemocnice Hradec Králové,IV. interní hematologická klinika,Sokolská 581,Hradec Králové,500 05 Všeobecná fakultní nemocnice v Praze,I. interní klinika - klinika hematologie,U Nemocnice 2,Praha,128 08 Fakultní nemocnice Královské Vinohrady,Interní hematologická klinika,Šrobárova 1150/50,Praha,100 34 |
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