An observational study in B Cell Lymphocytic Leukemia and B Cell Non-Hodgkin's Lymphoma, sponsored by Ottawa Hospital Research Institute. Status unknown. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by Ottawa Hospital Research Institute · Observational
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:
190 studies on the registry are indexed under Leukemia, B-Cell; 52 are open to participants now.
This study's planned enrollment of 160 is above the median of 120 across 22 observational studies indexed under Leukemia, B-Cell.
Browse Leukemia, B-Cell studies →Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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?
Blood samples will be collected at 4 specified time points from each participant.
Time frame: 2 years
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.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2018; primary completion for Mar 2021, 36 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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