A Study of Parsaclisib in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:October 5, 2017
End Date:May 2021
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, Multicenter Study of Parsaclisib, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of
2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma
(MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.


Inclusion Criteria:

- Men and women, aged 18 years or older.

- Documented failure to achieve at least PR with, or documented disease progression
after, the most recent treatment regimen.

- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Exclusion Criteria:

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

- 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 first dose of study treatment.

- Active graft-versus-host disease.

- Liver 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
24
sites
1653 West Congress Parkway
Chicago, Illinois 60612
Phone: 312-942-5978
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-996-8400
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Phone: 734-232-2883
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901 West 38th Street
Austin, Texas 78705
Phone: 512-421-4100
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14860 Roscoe Boulevard
Brooksville, Florida 34613
Phone: 352-596-1770
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4777 East Galbraith Road
Cincinnati, Ohio 45236
Phone: 513-751-2273
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Denver, Colorado 80218
Phone: 303-418-7639
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Durham, North Carolina 27710
Phone: 919-423-0632
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Eugene, Oregon 97401
Phone: 541-683-5001
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10 Corneel Heymanslaan
Gent, Oost-Vlaanderen 9000
Phone: 3293322132
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Gettysburg, Pennsylvania 17325
Phone: 717-334-4033
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Hattiesburg, Mississippi 39401
Phone: 601-288-2495
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-3148
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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New Hyde Park, New York 11042
Phone: 516-488-2918
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8915 West Golf Road
Niles, Illinois 60714
Phone: 847-827-9060
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Philadelphia, Pennsylvania 19104
Phone: 215-662-3933
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Portland, Oregon 97227
Phone: 503-249-3315
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5206 Research Drive
San Antonio, Texas 78240
Phone: 210-595-5300
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Santa Rosa, California 95403
Phone: 707-521-3826
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Tampa, Florida 33612
Phone: 813-745-8212
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The Woodlands, Texas 77380
Phone: 832-703-9128
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910 East Houston Street
Tyler, Texas 75702
Phone: 903-579-9800
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500 East Central Avenue
Winter Haven, Florida 33880
Phone: 863-293-1191
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2811 Tieton Drive
Yakima, Washington 98902
Phone: 509-574-3535
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