Clinical Trial TitleEffect of blinatumomab on minimal residual disease in subjects with diffuse large B-cell lymphoma post-autologous hematopoietic stem-cell transplantation.
Clinical Trial Protocol Description:
The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). Diffuse large B-cell lymphoma is a cancer of B-lymphocytes. In DLBCL, the abnormal B-cell lymphocytes are larger than normal, and they have stopped responding to signals that usually limit the growth and reproduction of cells. This specific subtype of lymphoma is called diffuse large B-cell because the malignant large B-cells grow within a lymph node in random locations throughout the lymph node (diffusely) without a specific pattern or structural design.
Residual cancerous cells can linger in tiny numbers in the blood and evade detection by traditional tests. This study will use a research test to detect traces of cancer in participating subject’s blood called minimal residual disease (MRD). The test identifies the presence or absence of residual cancer in the blood (MRD positive or MRD negative).
This study is being done to learn more about blinatumomab in people with high-risk DLBCL. It is also being done to learn more about the relationship (if any) between MRD and the rate of relapsing (disease returning) as there is a 1 in 3 chance the disease may return.
Blinatumomab is an anti-CD19/anti-CD3 bispecific monoclonal antibody with potential immune system stimulation and anticancer activities. This monoclonal antibody brings CD19-expressing tumor B-cells and cytotoxic T lymphocytes (CTLs) and helper T lymphocytes (HTLs) together, which may result in the CTL- and HTL-mediated cell death of CD19-expressing B-lymphocytes.
The study will consist of up to a 21-day screening period, a run-in period of up to 24 months, a 12-week treatment period (8 weeks of blinatumomab treatment followed by a 4-week treatment free period), a 30-day safety follow-up visit after the last dose of blinatumomab, and a long-term follow-up period that begins after the safety follow-up visit is completed until 1 year from the first dose of blinatumomab.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have received a blood stem-cell transplant of your own stem cells and be in complete remission (no sign of disease).
- Have MRD-positive test at any time during the run-in period of up to 24 months.
- Have adequate organ function determined less than or equal to 2 weeks prior to blinatumomab treatment.
You will be excluded from the study if any of the following criteria apply to you:
- Have disease that includes central nervous system involvement.
- Have received anti-CD19 directed treatment before.
- Have had an alloHSCT before.
This is a partial list of inclusion and exclusion criteria.