Detail of the clinical trial
| Title of the trial | An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigators Choice in Adult Patients with Relapsed or Refractory CD-22 positive acute Lymphoblastic Leukemia (ALL) |
|---|---|
| EudraCT number | 2011-005491-41 |
| Protocol number | B1931022 |
| Sponsor | Pfizer Inc., 235 East 42 nd Street, New York, NY 10017 USA |
| Indications | Oncology |
| Diagnosis | in Adult Patients with Relapsed or Refractory CD-22 positive acute Lymphoblastic Leukemia (ALL) |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2012 |
| Date of approval by Institute (SÚKL) | 16.5.2012 |
| Date of approval by EC | 27.6.2012 |
| Date of initiation CT in ČR | 15.11.2012 |
| Date of ending CT in ČR | 4.1.2017 |
| Notice | |
| Sites |
FN Královské Vinohrady, Interní hematolog. klinika, Šrobárova 50, Praha 10 FN Olomouc, hemato-onkolog. klinika-I.P. Pavlova 6, Olomouc (discontinued) FN Brno, Interní hematologická a onkologická klinika, Jihlavská 20, Brno 625 00 FNHK, II. interní klinika - odd. klinické hematologie, Sokolská 581, 500 05 ÚHKT, U Nemocnice 2, Praha 2 128 20 (discontinued) |
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