Parsaclisib in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 7, 2018
End Date:December 13, 2020
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 1, Open-Label, Dose-Finding Study of Parsaclisib in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

The purpose of this study is to evaluate the safety and tolerability of parsaclisib when
combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with
relapsed or refractory B-cell lymphoma.


Inclusion Criteria:

- Men and women, aged 18 years or older on the day of signing the Informed Consent Form
(ICF).

- Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.

- Participants with DLBCL, MZL or MCL must have received at least 1 prior line of
systemic therapy with documented progression or documented failure to achieve CR or PR
after the most recent systemic treatment regimen.

- Participants with FL must have received at least 2 prior lines of systemic therapy
with documented progression or documented failure to achieve CR or PR after the most
recent systemic treatment regimen.

- Ineligible for stem cell transplant.

- Participants with DLBCL must have failed or refused stem cell transplantation or
failed first-line salvage therapy if ineligible for transplantation.

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

- Life expectancy of > 3 months.

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 (see
Appendix D).

- Willingness to avoid pregnancy or fathering a child.

- Ability to comprehend and willingness to sign an ICF

Exclusion Criteria:

- Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).

- Histologically confirmed rare non-Hodgkin B-cell subtypes.

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

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

- For participants to be treated with bendamustine (Treatment B), prior treatment with
bendamustine (within 12 months of the start of study treatment). Participants with
prior bendamustine treatment (> 12 months before the start of study treatment) are
eligible if they meet the following criteria:

- Did not discontinue because of tolerability concerns.

- Achieved either partial response (PR) or complete response (CR) to the
bendamustine regimen of at least 12 months in duration before
relapse/progression.

- Experienced progression following a regimen containing an alkylating agent.

- For participants to be treated with ibrutinib (Treatment C), prior treatment with a
Bruton's tyrosine kinase (BTK) 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 following allogeneic transplant.

- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
We found this trial at
10
sites
2130 Northeast Interstate 410 Loop
San Antonio, Texas 78217
Phone: 210-595-5300
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-2950
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Austin, Texas 78731
Phone: 512-421-4100
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Brescia, 25123
Phone: +390303998571
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Dallas, Texas 75246
Phone: 214-370-1000
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Houston, Texas 77054
Phone: 713-798-2950
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Indianapolis, Indiana 46237
Phone: 317-528-7298
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Phone: 702-952-3400
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Phone: 210-656-7177
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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Tucson, Arizona 85719
Phone: 520-626-5683
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Tucson, AZ
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