Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and
because it was unlikely that the study would meet the estimated enrollment of approximately
978 subjects. The decision was not prompted by the identification of any safety signals in
this or other studies. Active treatment and follow-up of the already enrolled subjects was
continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to
one year after active treatment.

Inclusion Criteria:

- Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have
received 1 or 2 prior regimens, at least 1 of which should have contained
administration of rituximab (either as a single agent or in combination).

- Age 18 years or older.

- ECOG performance status <= 2.

- ANC >= 1.5 x 10^9/L (1500/mL) and platelets >= 75 x 10^9/L (75,000/mL), serum
creatinine <= 1.5 x ULN and urine protein to creatinine ratio of <= 0.5, total
bilirubin <= 1.5 x ULN, AST and ALT <= 2.5 x ULN.

- At least 1 measurable disease lesion that is >= 1.5 cm x 1.5 cm by CT or MRI, in an
area of no prior radiation therapy, or documented progression in an area that was
previously irradiated.

Exclusion Criteria:

- Subjects with clinical evidence of transformation to a more aggressive subtype of
lymphoma or grade 3b follicular lymphoma.

- Subjects whose disease is rituximab refractory, meaning that they did not have a CR or
PR, or that they experienced disease progression within 6 months from the initiation
of the rituximab or rituximab containing treatment regimen administered immediately
preceding study enrollment.