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 |
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.
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
4777 East Galbraith Road
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
Phone: 513-751-2273
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1720 2nd Ave S
Birmingham, Alabama 35233
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
Ann Arbor, Michigan 48109
Phone: 734-232-2883
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1653 West Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
Phone: 312-942-5978
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2160 South 1st Avenue
Maywood, Illinois 60153
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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Philadelphia, Pennsylvania 19104
Phone: 215-662-3933
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500 East Central Avenue
Winter Haven, Florida 33880
Winter Haven, Florida 33880
Phone: 863-293-1191
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2811 Tieton Drive
Yakima, Washington 98902
Yakima, Washington 98902
Phone: 509-574-3535
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