LymphomaPhase 1NCT03039114
Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)
A Phase 1 study testing Parsaclisib, Hexal and Gazyvaro in people with Lymphoma, run by Incyte Corporation at 21 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Parsaclisib, Hexal and Gazyvaro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 15 Feb 2017to 30 Mar 2021
- 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
- Histologically confirmed FL.
- Documented CD20+ FL.
- Relapsed or refractory to any prior rituximab-containing regimen.
- Previously treated with a maximum of 4 cancer-directed treatment regimens.
- At least 1 measurable lesion > 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging.
- Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Who cannot join
- Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
- History of central nervous system lymphoma (either primary or metastatic).
- Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
- Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor.
- Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria:
Show all 14Show fewer
- Did not discontinue because of tolerability concerns.
- Achieved either partial or CR to the bendamustine regimen of at least 12 months in duration before relapse/progression.
- Experienced progression following a regimen containing an alkylating agent.
- Received prior obinutuzumab.
- Received rituximab within 4 weeks of study start.
- Prior treatment-related toxicities that have not resolved to ≤ Grade 1 before the date of study drug administration except for stable chronic toxicities (≤ Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
- Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States6 sites
Center for Cancer and Blood Disorders (CCBD) - Bethesda
Bethesda, Maryland, 20817
University of Kansas Cancer Center
Fairway, Kansas, 66205
Banner Health
Gilbert, Arizona, 85234
University of California, San Diego
La Jolla, California, 92093
Clinical Research Alliance
Lake Success, New York, 11042
Froedtert & Medical College of Wisconsin & Affiliated Hospitals
Milwaukee, Wisconsin, 53226
Italy5 sites
Centro di Riferimento Oncologico
Aviano, 33081
Azienda Ospedaliero Universitaria Di Bologna
Bologna, 40138
Policlinico S. Orsola-Ematologia LA Seragnoli
Bologna, 40138
A.O. Spedali Civili
Brescia, 25123
UO Ematologia ASST Spedali Civili
Brescia, 25123
Spain5 sites
Hospital Germans Trias Pujol
Barcelona, 08916
Hospital Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen del Rocío
Seville, 41013
Denmark3 sites
Aarhus University Hospital
Aarhus, DK-8000
Rigshospitalet
Copenhagen, DK-2100
The Finsen Centre, National Hospital
Copenhagen, DK-2100
About this study
Official title: An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma (CITADEL-102)
The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).
- Conditions
- Lymphoma
- Being tested
- Parsaclisib, Hexal, Gazyvaro
- Keywords
- Follicular lymphoma, relapsed, refractory, non-Hodgkin lymphoma, phosphatidylinositol 3-kinase (PI3K)
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Recurrence, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called INCB050465
Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
HexalDrug
Also called Bendamustine
Bendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints.
GazyvaroDrug
Also called Gazyva®, Obinutuzumab
Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
| Study group | Role | What they receive |
|---|---|---|
| Parsaclisib + Hexal and Gazyvaro | Experimental | Not described Receives: Drug: Parsaclisib; Drug: Hexal; Drug: Gazyvaro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)
Measured: Screening through 30-35 days after end of treatment, up to approximately 34 months per subject
Secondary outcomes (5)
Objective response rate based on Lugano classification criteria
Defined as percentage of subjects with a complete response (CR) and partial response (PR), as determined by investigator assessment of response
Measured: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Complete response rate based on Lugano classification criteria
Defined as percentage of subjects who achieve a best overall response of CR
Measured: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Duration of response
Defined as time from first documented evidence of CR or PR until earliest date of disease progression or death due to any cause.
Measured: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Progression-free survival
Defined as time from the date of the first dose of study drug until the earliest date of disease progression (determined by radiographic disease assessment/Lugano classification criteria) or death due to any cause.
Measured: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Overall survival
Defined as the time from the date of the first dose of study drug until death due to any cause.
Measured: From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start15 Feb 2017
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fitzroy Dawkins, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039114
- Sponsor's protocol ID
- INCB 50465-102 (CITADEL-102)
- Other IDs
- Parsaclisib, 2016-002829-11, 2016
- Status last verified
- Aug 2025
- First submitted
- 31 Jan 2017
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma (CITADEL-102)
- ClinicalTrials.gov ID
- NCT03039114
- Acronym / sponsor ID
- INCB 50465-102 (CITADEL-102)
- Conditions
- Lymphoma
- Keywords
- Follicular lymphoma, relapsed, refractory, non-Hodgkin lymphoma, phosphatidylinositol 3-kinase (PI3K)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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 efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parsaclisib + Hexal and Gazyvaro | Experimental | Drug: Parsaclisib, Drug: Hexal, Drug: Gazyvaro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed FL.
- Documented CD20+ FL.
- Relapsed or refractory to any prior rituximab-containing regimen.
- Previously treated with a maximum of 4 cancer-directed treatment regimens.
- At least 1 measurable lesion > 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging.
Key exclusion criteria (14 listed)
- Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
- History of central nervous system lymphoma (either primary or metastatic).
- Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
- Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
- Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor.
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 at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly. | Drug | Parsaclisib + Hexal and Gazyvaro |
| HexalAlso: BendamustineBendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints. | Drug | Parsaclisib + Hexal and Gazyvaro |
| GazyvaroAlso: Gazyva®, ObinutuzumabObinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints. | Drug | Parsaclisib + Hexal and Gazyvaro |
Primary outcome
Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)
Time frame: Screening through 30-35 days after end of treatment, up to approximately 34 months per subject
5 secondary outcomes
Objective response rate based on Lugano classification criteria
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Complete response rate based on Lugano classification criteria
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Duration of response
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Progression-free survival
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Overall survival
Time frame: From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject
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.
- Individual participant dataSharing planned: Undecided
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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.
Fitzroy Dawkins, MD study director
Incyte Corporation
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Parsaclisib, Hexal and Gazyvaro in people with Lymphoma, run by Incyte Corporation at 21 sites in 6 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 7 inclusion and 14 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, Italy, Spain, Denmark, Czechia and 1 more country. 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?
Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs) (time frame: Screening through 30-35 days after end of treatment, up to approximately 34 months per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.