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LymphomaPhase 2NCT04434937

Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

A Phase 2 study testing parsaclisib in people with Lymphoma, run by Incyte Biosciences Japan GK at 30 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
30 sitesJapan
Study dates
30 Sep 2020to 13 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 or female Japanese participant who must be ≥ 18 years of age
  • Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures
  • Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a
  • Ineligible for HSCT
  • Must have been treated with at least 2 prior systemic therapies for FL
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the LD and ≥ 1.0 cm in the LPD, respectively) as assessed by CT or MRI
Show all 14Show fewer
  • Participants must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy collected after the completion of last therapy. An earlier archived lymph node or tissue biopsy is acceptable if hospitalization is required for biopsy (eg. no superficial lymph node) and SUVmax by FDG-PET is < 14
  • ECOG performance status 0 to 2
  • Life expectancy ≥ 12 weeks
  • Adequate hematologic, hepatic, and renal functions ANC ≥ 1.0 × 109/L Hemoglobin ≥ 8.0 g/dL. Platelet count ≥ 50 × 109/L. Total bilirubin ≤ 1.5 × ULN. Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.
  • ALT/AST ≤ 2.5× ULN or ≤ 5 × ULN in the presence of liver involvement. Calculated creatinine clearance ≥ 40 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 40 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.
  • Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
  • Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
  • Male participants should avoid fathering children from screening through at least 93 days after the last dose of study treatment.

Who cannot join

  • Known histological transformation from indolent NHL to DLBCL
  • History of central nervous system lymphoma (either primary or metastatic)
  • Prior treatment with the following:
  • Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).
  • Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
  • Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months before the date of study treatment administration
Show all 13Show fewer
  • Active graft-versus-host disease
  • Use of immunosuppressive therapy within 28 days of the date of study treatment administration
  • Concurrent anticancer therapy
  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease
  • Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
  • Hepatitis B (HBV) or HCV infection
  • Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Japan30 sites

  • Ja-Aichi Anjo Kosei Hospital

    Anjo, 446-8602

  • University of Fukui Hospital

    Fukui, 910-1193

  • Jcho Kyushu Hospital

    Fukuoka, 806-8501

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Kansai Medical University Hospital

    Hirakata, 573-1191

  • Hokuyukai Sapporo Hokuyu Hospital

    Hokkaido, 003-0006

  • Hyogo College of Medicine Hospital

    Hyōgo, 663-8501

  • Nho Mito Medical Center

    Ibaraki, 311-3193

  • Tokai University Hospital

    Isehara, 259-1193

  • Jiaikai Imamura General Hospital

    Kagoshima, 890-0064

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Nho Matsumoto Medical Center

    Matsumoto, 399-8701

  • Nho Shikoku Cancer Center

    Matsuyama, 791-0280

  • Nagano Red Cross Hospital

    Nagano, 380-8582

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, 466-8650

  • Red Cross Nagoya Daini Hospital

    Nagoya, 4668650

  • Tenri Hospital

    Nara, 632-8552

  • Miyagi Cancer Center

    Natori, 981-1293

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Ogaki Municipal Hospital

    Ōgaki, 5038502

  • Okayama University Hospital

    Okayama, 700-8558

  • Nho Hokkaido Cancer Center

    Sapporo, 003-0804

  • Tohoku University Hospital

    Sendai, 980-8574

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855

  • Yokohama City University Medical Center

    Yokohama, 232-0024

Other trials in Japan

About this study

Official title: A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Conditions
Lymphoma
Being tested
parsaclisib
Keywords
Follicular Lymphoma, Parsaclisib, PI3Kδ Inhibitor
Medical subject headings
Lymphoma, Lymphoma, Follicular

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 taken orally QD with water without regard to food except on mornings of PK clinic visits

Study groups in NCT04434937
Study groupRoleWhat they receive
parsaclisibExperimentalparsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
Receives: Drug: parsaclisib

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as defined by revised response criteria for lymphoma, as determined by an Independent Review Committee (IRC). CR: target nodes/nodal masses regressed to ≤1.5 centimeters (cm) in the longest transverse diameter (LDi); no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate. PR: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites; absent/regressed nonmeasured lesions (but no increase); spleen regressed by >50% in length beyond normal; and no new lesions.

    Measured: up to approximately 3 years

Secondary outcomes (7)

  1. Complete Response Rate (CRR)

    CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphoma, as determined by an IRC. CR was defined as: target nodes/nodal masses regressed to ≤1.5 cm in the LDi; no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate.

    Measured: up to approximately 3 years

  2. Duration of Response (DOR)

    DOR was defined as the time from the first documented evidence of CR or PR until disease progression or death from any cause among participants who achieved an objective response, as determined by radiographic disease assessment provided by an IRC. Progressive disease was defined as ≥1 of the following: abnormal individual node/lesion meeting specific criteria; new/recurrent splenomegaly; new/clear progression of pre-existing nonmeasured lesions; regrowth of any previously resolved lesions; new node >1.5 cm in any axis; new extranodal site >1.0 cm in any axis; assessable disease of any size attributable to lymphoma; new/recurrent involvement of bone marrow.

    Measured: up to 20.0 months

  3. Progression-free Survival (PFS)

    PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. Progressive disease was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

    Measured: up to approximately 3 years

  4. Overall Survival

    Overall survival was defined as the time from the date of the first dose of study treatment until death from any cause.

    Measured: up to approximately 3 years

  5. Best Percentage Change in Target Lesion Size From Baseline, as Determined by Independent Review Committee and the Investigator

    Target lesion size was measured by the sum of the products of the diameters of all target lesion sizes. The best percent change from Baseline was defined as the largest decrease, or smallest increase if no decrease, from Baseline in target lesion sizes on/before new anti-lymphoma therapy during the study. Percentage change was calculated as ([the post-Baseline value minus the Baseline value] / the Baseline value) x 100.

    Measured: up to approximately 3 years

  6. Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last administration of study drug.

    Measured: up to 1041 days

  7. Number of Participants With Any Grade 3 or Higher TEAE

    An adverse event was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last administration of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

    Measured: up to 1041 days

Timeline

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

  1. First posted17 Jun 2020
  2. Study start30 Sep 2020
  3. Primary completion16 Feb 2023
  4. Study completion13 Oct 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04434937
Sponsor's protocol ID
INCB 50465-213
Status last verified
Aug 2024
First submitted
15 Jun 2020
Last updated
23 Oct 2024
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

Publications

  • Fukuhara N, Yoshida I, Ishiguro T, Fujimoto K, Kuroda J, Uchida T, Yamamoto R, Ogawa Y, Hiramatsu Y, Ito T, Katagiri S, Nakazato T, Suzukawa K, Kinami K, Zhou M, Negoro E. PI3Kdelta Inhibitor Parsaclisib in Japanese Patients With Relapsed or Refractory Follicular Lymphoma. Cancer Sci. 2025 Aug;116(8):2189-2197. doi: 10.1111/cas.70046. Epub 2025 May 14.

    PubMed 40365847

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing parsaclisib in people with Lymphoma, run by Incyte Biosciences Japan GK at 30 sites in Japan.

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 14 inclusion and 13 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: up to approximately 3 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 NCT04434937, 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 23 Oct 2024.

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