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Mantle Cell LymphomaPhase 3CITADEL-310NCT04849715

A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 3 study testing parsaclisib, rituximab and bendamustine in people with Mantle Cell Lymphoma, 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Withdrawn

Withdrawn.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 BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
parsaclisib, rituximab and bendamustine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
11 Mar 2022to 7 Jul 2034
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.)
  • Have received no previous systemic anti-lymphoma therapies.
  • Pathologically confirmed MCL by local laboratory.
  • Histologically confirmed CD20 expression (by flow cytometry or immunohistochemistry) of the MCL cells as assessed by pathology.
  • Ineligible for high-dose chemotherapy and autologous stem cell transplantation.
  • Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
  • ECOG PS of 0 to 2.
  • Willingness to avoid pregnancy or fathering children.

Who cannot join

  • Presence of any lymphoma other than MCL.
  • Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
  • Requires treatment with potent inducers and inhibitors of CYP3A4
  • Inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
  • History of other malignancy within 2 years of study entry.
  • Known HIV infection, HBV or HCV.
Show all 11Show fewer
  • 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. Participant's positive for HCV antibody will be eligible if they are negative for HCV-RNA.
  • Clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization.
  • Abnormal ECG findings that are clinically meaningful per investigator's assessment.
  • Women who are pregnant or breastfeeding
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

About this study

Official title: A Phase 3, Randomized, Double-Blind Study Comparing Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab (BR), With Placebo and BR for the Treatment of Newly Diagnosed Mantle Cell Lymphoma

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.

Being tested
parsaclisib, rituximab, bendamustine, Placebo
Keywords
parsaclisib, newly diagnosed, bendamuastine, rituximab, PI3Kδ
Medical subject headings
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 will be administered orally once daily.

  • rituximabDrug

    Also called Rituxan

    rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.

  • bendamustineDrug

    Also called Bendeka, Treanda

    bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.

  • PlaceboDrug

    placebo will be administered orally once daily

Study groups in NCT04849715
Study groupRoleWhat they receive
Treatment Group AActive comparatorParticipants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
Receives: Drug: parsaclisib; Drug: rituximab; Drug: bendamustine
Treatment group BPlacebo comparatorParticipants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.
Receives: Drug: rituximab; Drug: bendamustine; Drug: Placebo

What is being measured

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

  1. Progression Free Survival

    Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first.

    Measured: 7 years

Secondary outcomes (10)

  1. Overall Survival

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

    Measured: 10 years

  2. Objective Response Rate

    Defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.

    Measured: 7 Years

  3. Complete Response Rate

    Defined as the proportion of participants with a CR as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.

    Measured: 7 Years

  4. Duration of Response

    Defined as the time from first-documented evidence of CR or PR until first documented disease progression or death from any cause, whichever happens first, among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.

    Measured: 7 Years

  5. Duration Of Complete Response

    Defined as the time from the first evidence of CR to the date of first documented disease progression or death from any cause, whichever happens first, among participants who achieve a CR, as determined by radiographic disease assessment provided by an IRC.

    Measured: 7 Years

  6. Disease Control Rate

    Defined as the proportion of participants who achieved a response of CR, PR, or Stable Disease (SD) assessed by an IRC.

    Measured: 7 Years

  7. Event Free Survival

    Defined as the time from date of randomization to date of first documented progression, as determined by radiographic disease assessment provided by an IRC, administration of a new anti lymphoma treatment, or death from any cause, whichever happens first.

    Measured: 7 Years

  8. Time To Next anti-Lymphoma Treatment

    Defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment.

    Measured: 7 Years

  9. Progression-Free Survival on next anti-lymphoma treatment

    Defined as the time from the date of randomization to the date of first documented disease progression as reported by investigator after next anti-lymphoma treatment or death from any cause, or start of a third anti-lymphoma treatment since randomization, whichever happens first.

    Measured: 7 Years

  10. Treatment Emergent Adverse Events

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

    Measured: 7 Years

Timeline

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

  1. First posted19 Apr 2021
  2. Study start11 Mar 2022 (estimated)
  3. Primary completion15 Aug 2030 (estimated)
  4. Study completion7 Jul 2034 (estimated)

Why it stopped: business decision; no enrolled patients

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
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849715
Sponsor's protocol ID
INCB 50465-310
Acronym
CITADEL-310
Status last verified
Apr 2022
First submitted
16 Apr 2021
Last updated
29 Apr 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 bendamustine in people with Mantle Cell Lymphoma, 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 11 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 29 Apr 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 (time frame: 7 years). 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 NCT04849715.

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 29 Apr 2022.

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