B Cell Lymphocytic LeukemiaNCT03417414
Does CMV Induced Changes in NK Lymphocyte Biology Influence the Effectiveness of Antibody Therapy Used to Treat B Cell Lymphoproliferative Diseases?
An observational study of B Cell Lymphocytic Leukemia and B Cell Non-Hodgkin's Lymphoma, run by Ottawa Hospital Research Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- B Cell Lymphocytic Leukemia, B Cell Non-Hodgkin's Lymphoma
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Comorbidities or frailty that would limit estimated survival to <1 year.
- Will not receive active anti-CD20 containing remission induction therapy.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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)
- Gender
- 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.
- Medical subject headings
- Leukemia, B-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| B-CLL | Patients with B-Cell CLL | |
| B-NHL | Patients with B-Cell NHL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold Atkins, MD FRCP C, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417414
- Sponsor's protocol ID
- GNK Cells in CLL and NHL
- Status last verified
- Feb 2018
- First submitted
- 15 Dec 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does CMV Induced Changes in NK Lymphocyte Biology Influence the Effectiveness of Antibody Therapy Used to Treat B Cell Lymphoproliferative Diseases?
- ClinicalTrials.gov ID
- NCT03417414
- Acronym / sponsor ID
- GNK Cells in CLL and NHL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
- Gender
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-CLL | – | –Patients with B-Cell CLL |
| B-NHL | – | –Patients with B-Cell NHL |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Comorbidities or frailty that would limit estimated survival to <1 year.
- Will not receive active anti-CD20 containing remission induction therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Are circulating gNK cells capable of killing CD20+ lymphoma cells through rituximab mediated ADCC mechanisms.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for B Cell Lymphocytic Leukemia
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
RecruitingPhase 2
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
RecruitingPhase 1/2
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
Acute Lymphoblastic Leukemia
RecruitingPhase 2
A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingPhase 1/2
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Atkins, MD FRCP C principal investigator
The Ottawa Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of B Cell Lymphocytic Leukemia and B Cell Non-Hodgkin's Lymphoma, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harold Atkins, MD FRCPC (613-737-7700 ext. 70341, hatkins@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is the presence of gNK cells associated with better clinical responses in rituxan treated lymphoma patients? (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.