Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

Study Drug Administration:

Every study cycle will be 6 weeks. You may receive up to 4 cycles of blinatumomab. Each cycle
will start around 3, 6, 9, and 12 months after your stem cell transplant.

In each cycle, you will receive blinatumomab as a continuous infusion by vein for 4 weeks,
followed by a 2 week "rest period" during which you will not receive blinatumomab.

You will need to remain in the hospital for the first 2 cycles so that you can be checked on
for side effects.

Length of Study:

You may receive blinatumomab for up to 1 year. You will no longer be able to receive the
study drug if the disease comes back (if you do not have ALL), if the disease gets worse (if
you have a small amount of ALL), if intolerable side effects occur, or if you are unable to
follow study directions.

Study Visits:

Before each cycle:

- You will have a physical exam. As part of the physical exam, you will be checked for
graft versus host disease (GVHD, when transplanted donor tissue attacks the tissues of
the recipient's body).

- Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell
transplant.

- You will have a bone marrow biopsy and aspiration to check the status of the disease and
for cytogenetic testing.

Once a week during each cycle, blood (about 4 tablespoons) will be drawn for routine tests.

End of Study Visit:

About 2 weeks after your last dose of blinatumomab:

- You will have a physical exam.

- Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell
transplant.

- You will have a bone marrow biopsy and aspiration to check the status of the disease and
for cytogenetic testing.

This is an investigational study. Blinatumomab is FDA approved and commercially available for
the treatment of Philadelphia chromosome (Ph) negative B-ALL that has returned after
treatment. Its use in patients with Ph positive B-lineage ALL is investigational.

Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Patients 18-70 years of age.

2. Patients with B-lineage ALL in a) hematologic complete remission (CR) beyond CR1 at
time of transplant; patients beyond CR1 or with primary induction failure may be
without minimal residual disease, b) any residual disease defined by positive flow
>0.01%, detection of BCR-ABL transcript by PCR with a sensitivity of 1/10,000, or
detection of the t(9;22) translocation in any metaphases by cytogenetics at time of
transplant, or presence of the MLL gene.

3. Received an allogeneic HCT within the last 100 days. Enrollment within 30-100 days
after transplant, and after adequate recovery of counts defined as ANC >/= 0.5 x
10^9/L without daily use of myeloid growth factor and platelet > 20 x 10^9/L without
platelet transfusion within 1 week, and adequate organ function to receive
blinatumomab defined as creatinine clearance greater than 30 ml/min, ALT/AST < 5 x ULN
and serum bilirubin < 3 x ULN.

4. Performance status of 0, 1, or 2

Exclusion Criteria:

1. Relapsed ALL defined as >5% malignant blasts in bone marrow or peripheral blood.

2. Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are
acceptable.

3. Systemic steroid therapy unless for physiologic replacement

4. Uncontrolled disease/infection as judged by the treating physician

5. Active ALL in the central nervous system (CNS), as defined by >/= 5 leukocytes per
microL with identifiable blast cells in the CSF, and/or the presence of cranial-nerve
palsies

6. Pregnant or nursing women