A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

Inclusion Criteria:

- Pre-B ALL, low and high grade NHL who underwent an alloHSCT using posttransplant CY
GVHD prophylaxis (Pt-Cy alone or combination with MMF/tacrolimus or sirolimus) as
follows:

- Pre-B ALL patients in CR1 with high-risk features such as adverse cytogenetics
including t(9;22), t(4;11) or other MLL rearrangements, t(8;14), complex
karyotype (≥5 chromosomal abnormalities), hypodiploidy (<44 chromosomes), low
hypodiploidy (30-39 chromosomes)/near triploidy (60-68 chromosomes), high WBC
count at presentation (≥30,000), lack of achievement of complete remission after
standard induction chemotherapy (but achieved CR1 following salvage or
consolidation), or persistence of detectable disease after induction and
consolidation (intensification) or pre-transplant as documented on any of routine
clinical tests (morphology, flow cytometry, cytogenetics or molecular studies) OR
all Pre-B ALL patients in second and higher CR

- Low and high grade NHL following a nonmyeloablative (reduced-intensity
conditioning) transplant irrespective of pre-transplant disease status

- Patients should be at least 60 but not more than 180 days from transplant with
documented count recovery (ANC >1 x109/L, and non-transfused platelets >30x109/L) and
no evidence of disease progression

- ECOG performance status 0-2

- Ability to give informed consent

- In agreement to use an effective barrier method of birth control (hormonal or barrier
method of birth control; abstinence) to avoid pregnancy during the study and for a
minimum of 30 days after study treatment, for all male and female patients who are
fertile

- Age ≥18 years

- Patients may have received any number of prior regimens to achieve remission. Patients
previously treated with blinatumomab will be eligible as long as they did not
experience unacceptable toxicities with prior blinatumomab administration. If patient
was refractory (no response) to blinatumomab in the past, patient will be eligible if
there was no evidence of CD19 loss on leukemia cells.

Exclusion Criteria:

- Lack of engraftment (less than 85% donor DNA in bone marrow or peripheral blood after
allogeneic HSCT).

- Active or untreated disease in central nervous system or testes

- Patient has received chemotherapy or radiotherapy (with the exception of intrathecal
chemotherapy) within 2 weeks of starting blinatumomab. Patient could receive
intrathecal prophylactic chemotherapy within a week prior to starting blinatumomab.

- Patients with active uncontrolled infection or uncontrolled intercurrent illness
including, but not limited to symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.

- Patients with active acute GVHD (grade 2-4) and active moderate or severe chronic GVHD
with GVHD therapy initiation or escalation within 28 days. Patients who required
steroids for the treatment of GVHD will need to be off steroids for at least 2 weeks
before enrollment. (Topical steroids or physiologic adrenal replacement steroid doses
are allowed).

- Patients requiring calcineurin inhibitors (i.e. tacrolimus or sirolimus) or other
systemic immunosuppressants (cyclosporine (CNI); methotrexate or similar) for GVHD
prophylaxis or treatment within 2 weeks prior to study enrollment.

- Inadequate end organ function defined as AST, ALT, and alkaline phosphatase > 3X ULN,
bilirubin >=1.5X ULN, or creatinine >=2 mg/dL

- Patients with Ph-positive ALL who are eligible for post-transplant TKI maintenance
based on a demonstrated sensitivity to TKIs pre-transplant (patients with known
intolerance or resistance to TKI will be eligible)

- Evidence of progressive disease post-transplant

- Women who are pregnant or lactating

- Known hypersensitivity to blinatumomab

- Patients with a concurrent active malignancy for which they are receiving treatment

- Concurrent use of any other investigational drugs

- Patient who have a history or presence of clinically relevant CNS pathology such as
epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia,
Parkinson's disease, cerebellar disease, psychosis, or other significant CNS
abnormalities. A history of treated CNS leukemia or lymphoma will be allowed if recent
imaging and CSF studies confirm the absence of active CNS disease at the time of study
entry

- Weight <45 kg

- Patients receiving other post-transplant maintenance therapies

- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis
B virus or hepatitis C virus (HCV)