Phase 3 Study of Inotuzumab Ozogamicin versus Investigator's Choice of Chemotherapy in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Update Il y a 5 ans
Reference: EUCTR2011-005491-41

Woman and Man

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To compare the hematological remission, defined as CR (both CR and CRi), as reported by the external independent endpoint adjudication committee, in patients with relapsed/refractory ALL randomized to receive inotuzumab ozogamicin (Arm A) versus patients randomized to receive active comparator (Arm B).

Inclusion criteria

  • Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia