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

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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
Houston, Texas 77005
Principal Investigator: Dr. Crow
Phone: 832-703-9074
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Ann Arbor, Michigan 48109
Principal Investigator: Dr. Phillips
Phone: 734-936-2740
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Birmingham, Alabama
Principal Investigator: Dr. Mehta
Phone: 205-934-0337
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4875 Higbee Avenue Northwest
Canton, Ohio 44718
Principal Investigator: Dr. Gabrail
Phone: 330-492-3345
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Canton, OH
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Charleston, South Carolina 29403
Principal Investigator: Dr. Ellison
Phone: 843-577-6957
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Charleston, SC
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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...
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5841 South Maryland Avenue
Chicago, Illinois 60637
Principal Investigator: Shuo Ma
Phone: 630-574-0103
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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...
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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...
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Gettysburg, Pennsylvania 17325
Principal Investigator: Dr Shah
Phone: 717-334-4033
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Glenwood Springs, Colorado 81601
Principal Investigator: Dr. Armas
Phone: 970-384-7574
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Grand Junction, Colorado 81501
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Kansas City, Missouri 64111
Principal Investigator: Shahzad Raza
Phone: 816-932-2881
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1 Lakeshore Drive
Lake Charles, Louisiana 70601
Principal Investigator: Dr. Khan
Phone: 337-602-6642
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Lake Success, New York 11042
Principal Investigator: Dr. Coleman
Phone: 516-216-1797
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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...
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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...
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Miami, Florida 33175
Principal Investigator: Dr. Geronilla
Phone: 305-220-2727
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Miami, Florida 33136
Principal Investigator: Dr. Lossos
Phone: 305-243-7648
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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...
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333 East 38th Street
New York, New York 10016
Principal Investigator: Dr. Diefenbach
Phone: 212-263-4431
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Nyack, New York 10960
Principal Investigator: Dr. Cohen
Phone: 845-362-1750
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Petaluma, California 94954
Principal Investigator: Dr. Stanton
Phone: 707-521-3830
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Phoenix, Arizona 85016
Principal Investigator: Dr. Nagaiah
Phone: 602-277-4868
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600 South Dixie Highway
Plantation, Florida 33324
Principal Investigator: Dr. Tache
Phone: 561-447-0614
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Redondo Beach, California 90277
Principal Investigator: Dr. Sikaria
Phone: 310-750-3381
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51 Hitchcock Way
Santa Barbara, California 93105
Principal Investigator: Dr. Greenwald
Phone: 805-879-0644
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Santa Maria, California 93454
Principal Investigator: Dr. Dichmann
Phone: 805-346-3461
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Santa Monica, California 90404
Principal Investigator: Dr. De Vos
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Seattle, Washington 98109
Principal Investigator: Dr. Smith
Phone: 206-474-2816
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South Brisbane, Queensland
Principal Investigator: Dr. Durrant
Phone: +617 3737 4745
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14860 Roscoe Boulevard
Spring Hill, Florida 34606
Principal Investigator: Dr. Caradonna
Phone: 352-364-9401
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White Plains, New York 10601
Principal Investigator: Dr. Cho
Phone: 914-849-7591
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Whittier, California 90603
Principal Investigator: Dr. Cheung
Phone: 562-693-4477
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