Does CMV Induced Changes in NK Lymphocyte Biology Influence the Effectiveness of Antibody Therapy Used to Treat B Cell Lymphoproliferative Diseases?

NCT03417414 | Unknown

• 1 other identifier: GNK Cells in CLL and NHL
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

B Cell Lymphocytic Leukemia; B Cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Are circulating gNK cells capable of killing CD20+ lymphoma cells through rituximab mediated ADCC mechanisms.

  2 years

Study Arms (2)

B-CLL

Patients with B-Cell CLL

B-NHL

Patients with B-Cell NHL

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Comorbidities or frailty that would limit estimated survival to \<1 year.
• Will not receive active anti-CD20 containing remission induction therapy.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

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.

MeSH Terms

Conditions

Leukemia, B-Cell; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma

Study Officials

• Harold Atkins, MD FRCP C

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harold Atkins, MD FRCPC

CONTACT

613-737-7700; hatkins@toh.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 31, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share