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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/29/2018
Start Date:November 2015
End Date:March 31, 2020
Contact:Hannah Campbell, BS
Email:hac2012@med.cornell.edu
Phone:(212) 745-1305

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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.

Inclusion Criteria:

1. 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.

2. Treatment plan that includes at least two doses of anti-CD20 antibody and longitudinal
follow up over at least a one-month time span.

Exclusion Criteria:

1. Hgb less than 8.0 g/dL or Hct less than 25% (transfusions or growth factors are
permissible).

2. Treatment with any anti-CD20 antibody within the past 12 months.
We found this trial at
1
site
445 E 69th St
New York, New York 10021
(212) 746-1067
Phone: 212-746-1305
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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from
New York, NY
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