This research study is studying Blinatumomab as a possible treatment for Indolent Non-Hodgkin Lymphoma (NHL).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
Massachusetts general Hospital
Boston, Massachusetts, United States
Overall Response Rate (ORR)
Count of participants achieving a complete or partial response according to the revised response criteria for malignant lymphoma (2014). A complete response is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a complete response, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable. A partial response is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
Time frame: at completion of treatment (6 months)
Progression Free Survival
Progression free survival is defined as the duration of time from start of treatment to time of documentation of disease progression according to the revised response criteria for malignant lymphoma (2014), death, or loss to follow-up. Progressive disease is defined as appearance of a new PET positive lesion greater than 1.5 cm in any axis, 50% or greater increase in the sum of the products of the greatest diameters (SPD) of more than one node, 50% or greater increase in longest diameter of a previously identified node less than 1 cm in short axis. There must also be a 50% increase from nadir in the SPD of any previous lesions.
Time frame: 5 years
Time To Response Rate
Time to response is defined as the duration of time from start of treatment to the achievement of a complete response (CR) or partial response (PR) according to the revised response criteria for malignant lymphoma (2014). A CR is defined as regression of involved nodes to normal size (1.5 cm or less in their greatest transverse diameter for nodes 1.5 cm or greater before therapy). Involved nodes 1.1 - 1.5 cm in their greatest transverse diameter before treatment must have decreased to less than 1 cm in this measure after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). For a CR, the spleen, if enlarged before therapy on a CT scan, must also have regressed in size and must not be palpable. A PR is defined as 50% or greater decrease in SPD of up to 6 largest dominant masses. There must also be no new sites of disease or increases in the size of the other nodes, liver, or spleen. Splenic/hepatic nodules must regress by at least 50% in SPD.
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Time frame: 4 months
Duration of Response
Duration of response is defined as the time from response (complete or partial response according to the revised response criteria for malignant lymphoma 2014) to disease progression, death, or loss to follow-up.
Time frame: 5 years
Rate Patients Are Discontinued From The Drug Due to Toxicity
Number of patients who discontinued study treatment early due to one or more toxicities.
Time frame: 2 years
Overall Survival
Overall survival is defined the duration of time from start of treatment to time of death or loss to follow up.
Time frame: 5 years