INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
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ClinicalTrials.gov Identifier: NCT03424122 |
Recruitment Status :
Completed
First Posted : February 6, 2018
Last Update Posted : June 29, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
B-cell Lymphoma | Drug: Parsaclisib Drug: Rituximab Drug: Bendamustine Drug: Ibrutinib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112) |
Actual Study Start Date : | July 2, 2018 |
Actual Primary Completion Date : | June 27, 2022 |
Actual Study Completion Date : | June 27, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment A
Parsaclisib + Rituximab
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Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Name: INCB050465 Drug: Rituximab Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Name: Rituxan |
Experimental: Treatment B
Parsaclisib + Bendamustine + Rituximab
|
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Name: INCB050465 Drug: Rituximab Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Other Name: Rituxan Drug: Bendamustine Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
Other Name: Treanda, Bendeka |
Experimental: Treatment C
Parsaclisib + Ibrutinib
|
Drug: Parsaclisib
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Other Name: INCB050465 Drug: Ibrutinib Ibrutinib administered orally once daily.
Other Name: Imbruvica |
- Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 12 months. ]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.
- Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
- Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib [ Time Frame: Up to approximately 1 month. ]Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424122
Study Director: | Peter Langmuir, MD | Incyte Corporation |
Responsible Party: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT03424122 |
Other Study ID Numbers: |
INCB 50465-112 (CITADEL-112) Parsaclisib ( Other Identifier: Incyte Corporation ) |
First Posted: | February 6, 2018 Key Record Dates |
Last Update Posted: | June 29, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Diffuse large B-cell lymphoma (DLBCL) follicular lymphoma (FL) marginal zone lymphoma (MZL) mantle cell lymphoma (MCL) phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor |
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Rituximab Bendamustine Hydrochloride Ibrutinib |
Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |