Does CMV Induced Changes in NK Lymphocyte Biology Influence the Effectiveness of Antibody Therapy Used to Treat B Cell Lymphoproliferative Diseases?
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|ClinicalTrials.gov Identifier: NCT03417414|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : February 7, 2018
|Condition or disease|
|B Cell Lymphocytic Leukemia B Cell Non-Hodgkin's Lymphoma|
CMV infection results in a unique population of highly effective ADCC effector cells (g-NK) in more than 50% of individuals. Unlike most NK cells, g-NK cells are long-lived and persist for years following primary infection. The g-NK population enlarges following antibody binding through their Fc receptors (FcR) and target engagement by the antibody. The addition of rituximab and other monoclonal antibodies directed against B lymphocyte targets to remission-induction therapy has improved the depth and durability of response for patients with B cell lymphoproliferative diseases, such as Non-hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The effects of rituximab and other monoclonal anti-cancer antibodies are at least partially mediated through ADCC mechanisms.
The purpose of this study is to examine the clinically relevant aspects of g-NK biology during antibody-containing therapy of lymphoproliferative diseases including whether the presence of g-NK might correlate with improved treatment responses.
Up to 160 patients with either B cell NHL or CLL will be enrolled in this study.
The study enrollment will occur over approximately 2 years. Patients will only be involved in this study until their blood samples are collected at the time point described below.
The following data will be abstracted from the clinical record over the course of the study:
- Age (at beginning of remission-induction therapy)
- Weight and height
- Pathological diagnosis including subtype and genetic testing when available.
- Stage at diagnosis
- Prognostic index score (IPI or FLIPI as appropriate)
- Date that remission-induction therapy begins
- Chemotherapy used for remission-induction.
- Dose of anti-CD20 antibody administered during remission-induction
- Remission status after 3 cycles of remission-induction therapy (if available)
- Details of maintenance therapy (drug, dose, schedule)
- Date of progression or relapse.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Does CMV Induced Changes in NK Lymphocyte Biology Influence the Effectiveness of Antibody Therapy Used to Treat B Cell Lymphoproliferative Diseases?|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Patients with B-Cell CLL
Patients with B-Cell NHL
- Is the presence of gNK cells associated with better clinical responses in rituxan treated lymphoma patients? [ Time Frame: 2 years ]Blood samples will be collected at 4 specified time points from each participant.
- Are circulating gNK cells capable of killing CD20+ lymphoma cells through rituximab mediated ADCC mechanisms. [ Time Frame: 2 years ]Blood samples will be collected at 4 specified time points from each participant.
Biospecimen Retention: Samples Without DNA
The CMV status of individuals will be measured by serology in the laboratory of Dr. Lee.
The presence and function of g-NK cells will be identified and quantified following staining with appropriate fluorescent monoclonal antibody conjugates using flow cytometry of peripheral blood.
Samples from individuals will be examined to determine changes over time associated with remission-induction and maintenance anti-CD20 based treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417414
|Contact: Harold Atkins, MD FRCPC||613-737-7700 ext email@example.com|
|Principal Investigator:||Harold Atkins, MD FRCP C||The Ottawa Hospital|