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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