An Open-Label Study of Parsaclisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:June 29, 2017
End Date:October 2021
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

Use our guide to learn which trials are right for you!

A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

The purpose of this study is to assess the objective response rate of parsaclisib treatment
in subjects with relapsed or refractory follicular lymphoma.


Inclusion Criteria:

- Aged 18 years or older.

- Histologically confirmed, relapsed or refractory, follicular B-cell NHL (follicular
lymphoma) Grade 1, 2, and 3a.

- Ineligible for hematopoietic stem cell transplant.

- Must have been treated with at least 2 prior systemic therapies.

- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥
1.0 cm in the longest perpendicular dimension as assessed by computed tomography or
magnetic resonance imaging.

- Must be willing to undergo an incisional, excisional, or core needle lymph node or
tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
archival tissue.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

- Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

- History of central nervous system lymphoma (either primary or metastatic).

- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K
inhibitor.

- Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
transplant within the last 3 months before the date of study treatment administration.

- Active graft-versus-host disease.

- Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be
eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody
will be eligible if they are negative for HCV-RNA.
We found this trial at
22
sites
Baltimore, Maryland 21229
Phone: 667-234-2966
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Albury,
Click here to add this to my saved trials
Beverly Hills, California 90211
Phone: 301-432-8931
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Canton, Ohio 44718
Phone: 330-492-3345
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29403
Phone: 843-577-6957
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Detroit, Michigan 48201
Phone: 313-576-9381
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Durham, North Carolina 27710
Phone: 919-681-4769
?
mi
from
Durham, NC
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
Phone: 601-288-2495
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
Kansas City, Missouri 64218
Phone: 816-276-4227
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kansas City, Missouri 64111
Phone: 816-932-2677
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
1 Lakeshore Drive
Lake Charles, Louisiana 70601
Phone: 337-602-6642
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lake Success, New York 11042
Phone: 516-488-2918
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
1100 Charlotte Avenue
Nashville, Tennessee 37203
Phone: 615-524-4469
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Phone: 215-615-4312
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plainville, Connecticut
Phone: 860-224-4408
?
mi
from
Plainville, CT
Click here to add this to my saved trials
Santa Rosa, California 95403
Phone: 707-521-3803
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Sarasota, Florida 34232
Phone: 941-957-1000
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
825 Eastlake Avenue East
Seattle, Washington 98109
Phone: 206-606-6721
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tempe, Arizona 85284
Phone: 480-416-5079
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
The Woodlands, Texas 77380
Phone: 832-703-9054
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
14860 Roscoe Boulevard
Weeki Wachee, Florida 34607
Phone: 352-364-9401
?
mi
from
Weeki Wachee, FL
Click here to add this to my saved trials
15111 Whittier Boulevard
Whittier, California 90603
Phone: 562-693-4477
?
mi
from
Whittier, CA
Click here to add this to my saved trials