An Open-label Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigatorâ??s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)
This research is being done to learn if an investigational study drug called inotuzumab ozogamicin is more effective in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) when compared to standard-of-care chemotherapy regimens. This study will also look at the sideeffects associated with inotuzumab ozogamicin and how the body distributes inotuzumab ozogamicin.
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No CriteriaInclusion Criteria:CD22 expression Adequate liver and renal functions Exclusion Criteria:Isolated extramedullary disease Active Central Nervous System [CNS] disease
Arm A: Experimental-- Drug: inotuzumab ozogamicin; Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle; Cycle length: 21-28 days; Total number of cycles: 6. Arm B: Active Comparator-- Drug: FLAG (fludarabine, cytarabine and G-CSF); Dose: cytarabine 2.0 g/m^2/day IV days 1-6; fludarabine 30 mg/m^2/day IV days 2-6; filgrastim (G-CSF) at 5 ug/kg/day per institutional standard of care; Cycle length: 28 days; Total number of cycles: 4.Drug: cytarabine and mitoxantrone; Dose: mitoxantrone 12 mg/m^2 IV days 1-3; cytarabine 200 mg/m^2/day IV over 7 days; Cycle length: 15-20 days; Total number of cycles: 4. Drug: HIDAC (high dose cytarabine); Dose: cytarabine 3 g/m^2 IV every 12 hours for up to 12 times.
12/19/2013 04:02 AM