A Study of Parsaclisib in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 27, 2017
End Date:March 2022
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, Open-Label, 2-Cohort Study of Parsaclisib, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment
regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL)
who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.


Inclusion Criteria:

- Men and women, aged 18 or older (except in South Korea, aged 19 or older).

- Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and
splenic subtypes.

- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse
diameter and ≥ 1.0 cm in the longest perpendicular diameter.

- Participants with splenic MZL who do not meet the radiographically measurable disease
criteria described herein are eligible for participation provided that bone marrow
infiltration of MZL is histologically confirmed.

- Participants must be willing to undergo an incisional or excisional lymph node or
tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
archival tissue.

- Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

- Evidence of diffuse large B-cell transformation.

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

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

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

- 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
34
sites
Seattle, Washington 98109
Principal Investigator: Dr. Smith
Phone: 206-474-2816
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Principal Investigator: Dr. Phillips
Phone: 734-936-2740
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Birmingham, Alabama
Principal Investigator: Dr. Mehta
Phone: 205-934-0337
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
4875 Higbee Avenue Northwest
Canton, Ohio 44718
Principal Investigator: Dr. Gabrail
Phone: 330-492-3345
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29403
Principal Investigator: Dr. Ellison
Phone: 843-577-6957
?
mi
from
Charleston, SC
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Dr. Venugopal
Phone: 312-942-8856
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 South Maryland Avenue
Chicago, Illinois 60637
Principal Investigator: Shuo Ma
Phone: 630-574-0103
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Dr. Janakiraman
Phone: 313-916-1784
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Dr. McKinney
Phone: 919-681-4769
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Gettysburg, Pennsylvania 17325
Principal Investigator: Dr Shah
Phone: 717-334-4033
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
Glenwood Springs, Colorado 81601
Principal Investigator: Dr. Armas
Phone: 970-384-7574
?
mi
from
Glenwood Springs, CO
Click here to add this to my saved trials
Grand Junction, Colorado 81501
?
mi
from
Grand Junction, CO
Click here to add this to my saved trials
Houston, Texas 77005
Principal Investigator: Dr. Crow
Phone: 832-703-9074
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64111
Principal Investigator: Shahzad Raza
Phone: 816-932-2881
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
1 Lakeshore Drive
Lake Charles, Louisiana 70601
Principal Investigator: Dr. Khan
Phone: 337-602-6642
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lake Success, New York 11042
Principal Investigator: Dr. Coleman
Phone: 516-216-1797
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Dr. Kingsley
Phone: 702-862-1113
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Scott Smith
Phone: 708-327-3142
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Miami, Florida 33175
Principal Investigator: Dr. Geronilla
Phone: 305-220-2727
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Dr. Lossos
Phone: 305-243-7648
?
mi
from
Miami, FL
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Dr. Hamandani
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
333 East 38th Street
New York, New York 10016
Principal Investigator: Dr. Diefenbach
Phone: 212-263-4431
?
mi
from
New York, NY
Click here to add this to my saved trials
Nyack, New York 10960
Principal Investigator: Dr. Cohen
Phone: 845-362-1750
?
mi
from
Nyack, NY
Click here to add this to my saved trials
Petaluma, California 94954
Principal Investigator: Dr. Stanton
Phone: 707-521-3830
?
mi
from
Petaluma, CA
Click here to add this to my saved trials
Phoenix, Arizona 85016
Principal Investigator: Dr. Nagaiah
Phone: 602-277-4868
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
600 South Dixie Highway
Plantation, Florida 33324
Principal Investigator: Dr. Tache
Phone: 561-447-0614
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Redondo Beach, California 90277
Principal Investigator: Dr. Sikaria
Phone: 310-750-3381
?
mi
from
Redondo Beach, CA
Click here to add this to my saved trials
51 Hitchcock Way
Santa Barbara, California 93105
Principal Investigator: Dr. Greenwald
Phone: 805-879-0644
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Santa Maria, California 93454
Principal Investigator: Dr. Dichmann
Phone: 805-346-3461
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
Santa Monica, California 90404
Principal Investigator: Dr. De Vos
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
South Brisbane, Queensland
Principal Investigator: Dr. Durrant
Phone: +617 3737 4745
?
mi
from
South Brisbane,
Click here to add this to my saved trials
14860 Roscoe Boulevard
Spring Hill, Florida 34606
Principal Investigator: Dr. Caradonna
Phone: 352-364-9401
?
mi
from
Spring Hill, FL
Click here to add this to my saved trials
White Plains, New York 10601
Principal Investigator: Dr. Cho
Phone: 914-849-7591
?
mi
from
White Plains, NY
Click here to add this to my saved trials
Whittier, California 90603
Principal Investigator: Dr. Cheung
Phone: 562-693-4477
?
mi
from
Whittier, CA
Click here to add this to my saved trials