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Follicular Lymphoma ( FL)Phase 3NCT04796922

To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)

A Phase 3 study testing parsaclisib, rituximab and obinutuzumab in people with Follicular Lymphoma ( FL) and Marginal Zone Lymphoma (MZL), run by Incyte Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
parsaclisib, rituximab and obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
30 Dec 2022to 25 Aug 2032
Phase
Phase 3
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

  • Male and female participants aged 18 years or older (Japan, aged 20 years or older).
  • Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
  • Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)
  • Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb
  • Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
  • ECOG PS of 0 to 2
  • Adequate organ functions including hematopoiesis, liver, and kidney
  • Willingness to avoid pregnancy or fathering children

Who cannot join

  • Women who are pregnant or breastfeeding.
  • Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma).
  • Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
  • Prior treatment with PI3K inhibitors.
  • Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs.
  • Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease.
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  • Known HIV infection.
  • HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA.
  • History of other malignancy within 2 years of study entry.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study.

About this study

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (MZL or FL) .

Being tested
parsaclisib, rituximab, obinutuzumab
Keywords
parsaclisib, Relapsed/Refractory, obinutuzumab, rituximab
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • parsaclisibDrug

    Also called INCB050465

    parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.

  • rituximabDrug

    rituximab will be administered intravenously on select days as per protocol.

  • obinutuzumabDrug

    obinutuzumab will be administered intravenously on select days as per protocol.

Study groups in NCT04796922
Study groupRoleWhat they receive
Treatment Group AExperimentalParticipants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
Receives: Drug: parsaclisib; Drug: rituximab; Drug: obinutuzumab
Treatment Group BPlacebo comparatorParticipants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab
Receives: Drug: rituximab; Drug: obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) in R/R FL and MZL participants

    Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.

    Measured: 62 months

Secondary outcomes (11)

  1. Progression Free Survival (PFS) in R/R FL participants

    Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.

    Measured: 62 months

  2. Overall Response Rate (ORR)

    Defined as the proportion of participants with a CR or PR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).

    Measured: 62 months

  3. Overall Survival (OS)

    Defined as the time from the date of randomization until death from any cause.

    Measured: 10 years

  4. Progression Free Survival (PFS) in R/R MZL participants

    Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.

    Measured: 62 months

  5. Complete Response Rate (CRR)

    Defined as the proportion of participants with a CR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).

    Measured: 62 months

  6. Duration of Response (DOR)

    Defined as the time from the date of first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, among participants who achieve an objective response as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).

    Measured: 62 months

  7. Disease Control Rate (DCR)

    Defined as the proportion of participants who achieve best overall response of CR, PR, or SD (Cheson et al 2014) as determined by IRC.

    Measured: 62 months

  8. Event Free Survival (EFS)

    Defined as the time from the date of randomization to the first documented disease progression as determined by radiographic disease assessment provided by IRC, the initiation of a new antilymphoma therapy, or death from any cause, whichever occurs first.

    Measured: 62 months

  9. Time To Next antiLymphoma Therapy (TTNLT)

    Defined as the time from the date of randomization to the first documented administration of a new antilymphoma therapy.

    Measured: 62 months

  10. Progression-Free Survival on next antilymphoma therapy (PFS2)

    Defined as the time from the date of randomization to the first documented disease progression as reported by the investigator after the initiation of a new antilymphoma therapy, death from any cause, or start of a third antilymphoma therapy since randomization in the study, whichever occurs first.

    Measured: 62 months

  11. Number of Treatment Emergent Adverse Events (TEAE's)

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    Measured: 62 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start30 Dec 2022 (estimated)
  3. Primary completion20 Dec 2028 (estimated)
  4. Study completion25 Aug 2032 (estimated)

Why it stopped: This study was withdrawn due to a business decision.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04796922
Sponsor's protocol ID
INCB 50465-302
Status last verified
Jul 2022
First submitted
10 Mar 2021
Last updated
18 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing parsaclisib, rituximab and obinutuzumab in people with Follicular Lymphoma ( FL) and Marginal Zone Lymphoma (MZL), run by Incyte Corporation.

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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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?

Progression Free Survival (PFS) in R/R FL and MZL participants (time frame: 62 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 NCT04796922.

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 18 Jul 2022.

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