Study of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

Study Drug Administration:

Each cycle is 28 (+/- 7) days.

If participant is found to be eligible to take part in this study, participant will receive
inotuzumab ozogamicin by vein over about 1 hour on Days 1, 8, and 15 of Cycle 1 and Days 1
and 8 of Cycles 2-6.

Participant may be given standard drugs to help prevent side effects. If participant's doctor
thinks it is needed, participant may also receive standard drugs by a spinal tap
(intrathecally) to help lower the risk of the disease coming back in the fluid surrounding
participant's brain. Participant's doctor will tell participant about these drugs, how they
will be given, and the possible risks.

Length of Treatment:

Participant may receive the study drug for up to 6 cycles. However, if participant's doctor
thinks it is in participant's best interest to receive a stem cell transplant from a donor,
participant will only receive 2-3 cycles.

Participant may be taken off study after Cycle 2 if the disease has had no response. However,
if the treating doctor and study doctor decide it is in participant's best interest,
participant may be able to receive up to 2 more cycles after that.

If there is no sign of cancer for 3 months but then small numbers of cancer cells come back,
participant may be eligible for retreatment again on the same schedule of study drug doses.
The study doctor will discuss this with participant.

Participant will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after the Cycle 6 visit.

Study Visits:

On Day 1 of Cycles 1-6:

- Participant will have a physical exam.

- Blood (about 2-3 tablespoons) will be drawn for routine tests.

At Weeks 2, 3, and 4 of Cycles 1-6, blood (about 2-3 tablespoons) will be drawn for routine
tests.

On Day 21 of Cycle 1 and then at the end of Cycles 2-6, participant will have a bone marrow
biopsy and/or aspiration to check the status of the disease.

Inclusion Criteria:

1. Patients at least 18 years of age.

2. Patients with B-lineage ALL in hematologic complete remission (CR) with molecular
failure (ie, had never achieved an MRD-negativity status before inotuzumab ozogamicin)
or had a molecular relapse (ie, became MRD positive after having been MRD negative)
starting at any time point after 3 months of frontline therapy. Molecular disease or
minimal residual disease is defined by a value of at least of 10^-4 by multicolor flow
cytometry.

3. Patients with B-lineage ALL in CR2 and beyond with molecular failure at any time point
after 2 months of salvage therapy are allowed

4. Performance status of 0, 1, or 2

5. Adequate organ function with creatinine clearance >/=15 ml/min and bilirubin <1.5 X
ULN and AST or ALT <2X ULN.

6. No active or co-existing malignancy with life expectancy less than 12 months.

Exclusion Criteria:

1. Pregnant or nursing women

2. Known to be HIV+

3. Ph+ ALL

4. Active and uncontrolled disease/infection as judged by the treating physician

5. Unable or unwilling to sign the consent form

6. Prior allogeneic stem cell transplantation

7. Active CNS or extramedullary disease

8. Monoclonal antibodies therapy within 2 weeks before study entry

9. Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or
low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate,
steroids) or any investigational drug within 2 weeks before study entry