This research study is a Phase II clinical trial. The overall purpose of this study is to
determine if blinatumomab is safe and effective for treating adult subjects with relapsed or
refractory indolent B cell NHL.
Blinatumomab will be infused causing T cells to recognize the Cancer and work against them.
This approach has been FDA approved for acute lymphocytic leukemia but has not yet been
approved for lymphoma.
Inclusion Criteria:
- Subjects must have histologically determined B cell NHL that is relapsed or primary
refractory after initial therapy.
- Follicular Lymphoma of any grade
- Marginal zone lymphoma (extranodal, nodal, or splenic). Patients with gastric
MALT must have progressed after H. Pylori therapy and radiation. Patients with
splenic MZL must have prior splenectomy.
- At least 1 prior line of chemoimmunotherapy if primary refractory or relapsed with in
one year. Subjects who respond to initial therapy for greater than one year must have
had at least 2 prior lines of therapy including one line with chemoimmunotherapy
including an anti-CD20 monoclonal antibody
- Measurable disease that has not been previously irradiated on PET-CT of at least
1.5cm,
- Age ≥18 years.
- ECOG performance status ≤2 ( see Appendix A)
- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥750/mcL
- platelets ≥75,000/mcL
- total bilirubin < 2.0 x upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal or 5 X ULN
- if due to lymphoma infiltration
- creatinine 2.0 X ULN OR
- creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels
above 2.0 X ULN .
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Participants who have had chemotherapy within 3 weeks, rituximab or obinutuzumab
within 4 weeks, or radioimmunotherapy within 6 weeks prior to entering the study, or
those who have not recovered from adverse events due to agents administered more than
3 weeks earlier. Subjects actively progressing within that window who have recovered
from toxicities of prior therapy are also eligible.
- Autologous stem cell transplantation within 12 weeks prior to study entry
- Prior allogeneic transplant
- Therapeutic doses of corticosteroids within 14 days prior to study entry, defined as
>20mg/day pf prednisone, or equivalent. Topical and/or inhaled steroids are permitted.
- Participants who are receiving any other investigational agents.
- Participants with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to blinatumomab
- Subjects with known HIV infection
- Pregnant or lactating subjects.
- Chronic infection with hepatitis B or hepatitis C virus
- History of or current relevant CNS pathology such as epilepsy, seizure,
paresis,aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain
syndrome, psychosis
- Prior history of another malignancy (except for non-melanoma skin cancer, in situ
cervical or breast cancer, or localized prostate cancer) unless disease free for at
least one year and felt at low risk of relapse by treating physician.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or
uncontrolled systemic fungal, bacterial, viral, or other infection, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements.
