Non Hodgkin Lymphoma Clinical Trial

A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma

Summary

This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT02811679

Recruitment Status:

Completed

Sponsor:

Massachusetts General Hospital

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There is 1 Location for this study

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Massachusetts general Hospital
Boston Massachusetts, 02114, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT02811679

Recruitment Status:

Completed

Sponsor:


Massachusetts General Hospital

How clear is this clinincal trial information?

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