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| ID | Type | Description | Link |
|---|---|---|---|
| Parsaclisib | Other Identifier | Incyte Corporation | |
| 2017-004088-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Parsaclisib + Rituximab |
|
| Treatment B | Experimental | Parsaclisib + Bendamustine + Rituximab |
|
| Treatment C | Experimental | Parsaclisib + Ibrutinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Parsaclisib administered orally once daily for 8 weeks followed by once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events (TEAEs) | A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment. | Up to approximately 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib | Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib. | Up to approximately 1 month. |
| Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Langmuir, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center - Out Pt. | Tucson | Arizona | 85719 | United States | ||
| Indiana Blood and Marrow Transplantation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38598516 | Derived | Sancho JM, Abrisqueta P, Kumar A, Cordoba R, Tani M, Langmuir P, Rappold E, Liu T, Lopez-Guillermo A. Safety and efficacy of parsaclisib in combination with rituximab, bendamustine + rituximab, or ibrutinib in patients with previously treated B-cell lymphoma: analysis of a phase 1 dose-finding study (CITADEL-112). Leuk Lymphoma. 2024 Jul;65(7):911-921. doi: 10.1080/10428194.2024.2331626. Epub 2024 Apr 10. |
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|
| Rituximab | Drug | Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group. |
|
|
| Bendamustine | Drug | Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles. |
|
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| Ibrutinib | Drug | Ibrutinib administered orally once daily. |
|
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Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib. |
| Up to approximately 1 month. |
| Indianapolis |
| Indiana |
| 46237 |
| United States |
| Comprehensive Cancer Center of Nevada | Las Vegas | Nevada | 89169 | United States |
| Texas Oncology | Austin | Texas | 78705 | United States |
| Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Smith Clinic | Houston | Texas | 77054 | United States |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | United States |
| Texas Oncology San Antonio | San Antonio | Texas | 78240 | United States |
| Asst Spedali Civili Di Brescia | Brescia | 25123 | Italy |
| Azienda Ospedaliera San Gerardo Di Monza | Monza | 20835 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56126 | Italy |
| Ospedale Delle Croci - Ematologia Ravenna | Ravenna | 48121 | Italy |
| Hospital Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital General Universitari Vall D Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Fundacion Jimenez Diaz University Hospital | Madrid | 28040 | Spain |
| Hospital Universitario Hm Sanchinarro | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Universitario Y Politecnic La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000656179 | parsaclisib |
| D000069283 | Rituximab |
| D000069461 | Bendamustine Hydrochloride |
| C551803 | ibrutinib |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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