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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.
This study does not involve the administration of study drug. This study will only require additional blood draws to identify how patients respond to rituximab and other anti-CD20 antibody therapy. It is expected that blood draws will occur on the same day in which an IV is placed to dose you with the anti-CD20 antibody or for other bloodwork being performed in order to avoid extra sticks. If you take part in this study, you will have additional blood drawn at the following time-points surround anti-CD20 antibody therapy: Pre Dose, Cycle 1 * Two 7.5 ml tubes (two teaspoons) of blood will be taken along with your other pre-chemotherapy bloodwork Post Dose, Cycle 1 * Two 5 ml tubes (three teaspoons) of blood will be taken Pre Dose, Cycle 2 * Two 5 ml tubes (two teaspoons) of blood will be taken Post Dose, Cycle 2 * Two 5 ml tubes (two teaspoons) of blood will be taken Pre Dose, Cycle 6 * Two 10 ml tubes (four teaspoons) of blood will be taken Post Dose, Cycle 6 * Two 10 ml tubes (four teaspoons) of blood will be taken Note: Two tubes will be taken at each draw. If no blood was drawn in the prior 8 weeks, 10 ml of blood will be taken per tube. For the first 4 draws (at cycle 1 and cycle 2, pre- and post-), the amount of blood being taken is to ensure that the patient does not have more than 50 ml of blood taken within an 8 week period.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Weill Medical College of Cornell University
New York, New York, United States
Start Date
November 1, 2015
Primary Completion Date
February 7, 2019
Completion Date
February 7, 2019
Last Updated
August 17, 2020
82
ACTUAL participants
Non Interventional
OTHER
Lead Sponsor
Weill Medical College of Cornell University
NCT05139017
NCT05529069
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