Polymorphisms at Distinct Genetic Loci Affect Response to Anti-CD20 Monoclonal Antibody Therapies

NCT02694913 | Completed

• 1 other identifier: 1503016060
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-interventional, R01-funded pilot study that will identify serum and cellular markers in patients' blood samples that can be used as short-term biomarkers of rituximab response. We hypothesize that serum complement levels, activation of natural killer cells, and clearance of peripheral B-cells will be accurate biomarkers of rituximab response, and may be correlated with long-term outcomes.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percentage of peripheral blood mononuclear cells that are B-cells, as measured by flow cytometry for CD19 performed on peripheral blood immediately prior to cycle 2

  1 month after the start of treatment

Interventions

Non Interventional OTHER

This is a non therapeutic, pilot study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any adult patient who has not received rituximab or other anti-CD20 antibody within the past year who is initiating rituximab or other anti-CD20 antibody treatment and has a treatment plan that includes at least two doses of anti-CD20 antibody and longitudinal follow up over at least a one-month time span.

You may qualify if:

• Any adult patient who has not received rituximab or other anti-CD20 antibody within the past year who is initiating rituximab or other anti-CD20 antibody treatment.
• Treatment plan that includes at least two doses of anti-CD20 antibody and longitudinal follow up over at least a one-month time span.

You may not qualify if:

• Hgb less than 8.0 g/dL or Hct less than 25% (transfusions or growth factors are permissible).
• Treatment with any anti-CD20 antibody within the past 12 months.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood will be taken to measure B-cell depletion. Any remaining sample will be stored for 15 years in the biobank.

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ari M Melnick, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 1, 2016
• Study Start: November 1, 2015
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)