Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an observational cohort study of patients with a new diagnosis of B cell Chronic Lymphocytic Leukemia or B cell Non-Hodgkin's Lymphoma who will receive an anti-CD20 monoclonal antibody treatment during the induction phase of their treatment. Throughout the study, patients will have four blood draws at specified time points throughout the study. The initial blood draw will be analysed test patients for Cytomegalovirus and conduct a g-NK cell analysis. The final three blood draws will be conducted to analyse the g-NK cells at specified time points. The objectives of this study are to: 1) characterize the frequency of CMV (+) and g-NK (+) individuals in the B-NHL and B-CLL populations, 2) Determine changes in circulating g-NK cells during and after anti-CD20 monoclonal antibody containing remission induction chemotherapy and 3) Evaluate whether the presence of g-NK cells improve the outcome of anti-CD20 monoclonal antibody containing remission induction treatment of patients with B-NHL or B-CLL.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-CLL | Patients with B-Cell CLL | ||
| B-NHL | Patients with B-Cell NHL |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Is the presence of gNK cells associated with better clinical responses in rituxan treated lymphoma patients? | Blood samples will be collected at 4 specified time points from each participant. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Are circulating gNK cells capable of killing CD20+ lymphoma cells through rituximab mediated ADCC mechanisms. | Blood samples will be collected at 4 specified time points from each participant. | 2 years |
Not provided
Inclusion Criteria:
New diagnosis of CD20 expressing B-NHL or CLL
o Up to 1/3rd of enrolled patients may have CLL. Enrollment of patients with CLL will be halted if this criterion is reached.
Will receive an anti-CD20 monoclonal antibody treatment (including rituximab, obinatuzumab) during the induction phase of treatment
Has not previously received cytotoxic chemotherapy medications
Able to provide informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with a new diagnosis of CD20 expressing B-NHL or CLL who will receive an anti-CD20 monoclonal antibody treatment during the induction phase of treatment who have not previously been exposed to cytotoxic chemotherapy medications.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harold Atkins, MD FRCPC | Contact | 613-737-7700 | 70341 | hatkins@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Harold Atkins, MD FRCP C | The Ottawa Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
Not provided
Not provided