Study: NCT01134575

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CMC-544 (Inotuzumab Ozogamycin)
Description: First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.~Part 2 CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CMC-544 (Inotuzumab Ozogamycin)
Description: First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.~Part 2 CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CMC-544 (Inotuzumab Ozogamycin)
Description: First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.~Part 2 CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.