B-cell LymphomaPhase 1NCT03424122
INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
A Phase 1 study testing Parsaclisib, Rituximab and Bendamustine in people with B-cell Lymphoma, run by Incyte Corporation at 21 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma
- What is being tested?
- Parsaclisib, Rituximab and Bendamustine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 2 Jul 2018to 27 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States9 sites
Texas Oncology
Austin, Texas, 78705
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Baylor College of Medicine
Houston, Texas, 77030
Smith Clinic
Houston, Texas, 77054
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89169
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Texas Oncology San Antonio
San Antonio, Texas, 78240
University of Arizona Cancer Center - Out Pt.
Tucson, Arizona, 85719
Spain8 sites
Hospital Germans Trias I Pujol
Badalona, 08916
Hospital General Universitari Vall D Hebron
Barcelona, 08035
Hospital Clinic I Provincial
Barcelona, 08036
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
Hospital Universitario Hm Sanchinarro
Madrid, 28050
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitario Y Politecnic La Fe
Valencia, 46026
Italy4 sites
Asst Spedali Civili Di Brescia
Brescia, 25123
Azienda Ospedaliera San Gerardo Di Monza
Monza, 20835
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Ospedale Delle Croci - Ematologia Ravenna
Ravenna, 48121
About this study
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)
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.
- Conditions
- B-cell Lymphoma
- Being tested
- Parsaclisib, Rituximab, Bendamustine, Ibrutinib
- Keywords
- Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called INCB050465
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
RituximabDrug
Also called Rituxan
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
BendamustineDrug
Also called Treanda, Bendeka
Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
IbrutinibDrug
Also called Imbruvica
Ibrutinib administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Parsaclisib + Rituximab Receives: Drug: Parsaclisib; Drug: Rituximab |
| Treatment B | Experimental | Parsaclisib + Bendamustine + Rituximab Receives: Drug: Parsaclisib; Drug: Rituximab; Drug: Bendamustine |
| Treatment C | Experimental | Parsaclisib + Ibrutinib Receives: Drug: Parsaclisib; Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 12 months.
Secondary outcomes (2)
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.
Measured: Up to approximately 1 month.
Apparent volume of distribution of parsaclisib in 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.
Measured: Up to approximately 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start2 Jul 2018
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Langmuir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424122
- Sponsor's protocol ID
- INCB 50465-112 (CITADEL-112)
- Other IDs
- Parsaclisib, 2017-004088-11, 2017
- Status last verified
- Aug 2025
- First submitted
- 25 Jan 2018
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38598516
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03424122
- Acronym / sponsor ID
- INCB 50465-112 (CITADEL-112)
- Conditions
- B-cell Lymphoma
- Keywords
- Diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Parsaclisib, Drug: RituximabParsaclisib + Rituximab |
| Treatment B | Experimental | Drug: Parsaclisib, Drug: Rituximab, Drug: BendamustineParsaclisib + Bendamustine + Rituximab |
| Treatment C | Experimental | Drug: Parsaclisib, Drug: IbrutinibParsaclisib + Ibrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParsaclisibAlso: INCB050465Parsaclisib administered orally once daily for 8 weeks followed by once weekly. | Drug | Treatment A, Treatment B, Treatment C |
| RituximabAlso: RituxanRituximab administered intravenously at the protocol-defined dose regimen according to treatment group. | Drug | Treatment A, Treatment B |
| BendamustineAlso: Treanda, BendekaBendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles. | Drug | Treatment B |
| IbrutinibAlso: ImbruvicaIbrutinib administered orally once daily. | Drug | Treatment C |
Primary outcome
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.
2 secondary outcomes
Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib
Time frame: Up to approximately 1 month.
Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib
Time frame: Up to approximately 1 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 38598516Sancho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Langmuir, MD study director
Incyte Corporation
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Parsaclisib, Rituximab and Bendamustine in people with B-cell Lymphoma, run by Incyte Corporation at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent adverse events (TEAEs) (time frame: Up to approximately 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03424122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.