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

Sponsor
Incyte Biosciences Japan GK (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04434937
Collaborator
(none)
40
Enrollment
30
Locations
1
Arm
48
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 30, 2020
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: parsaclisib

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

Drug: parsaclisib
parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
Other Names:
  • INCB050465

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [Up to approximately 2 years]

      Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014), as determined by an IRC

    Secondary Outcome Measures

    1. Complete response rate (CRR) [Up to approximately 2 years]

      Defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an IRC.

    2. Duration of response (DOR) [Up to approximately 2 years]

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

    3. Progression-free survival (PFS) [Up to approximately 2 years]

      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.

    4. Overall survival [Up to approximately 2 years]

      Defined as the time from the date of the first dose of study treatment until death from any cause

    5. Best percentage change in target lesion size [Up to approximately 2 years]

      Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of the diameters of all target lesion sizes.

    6. Number of participants with treatment-emergent adverse events (TEAEs) [Up to approximately 2 years]

      TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • 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.

    Exclusion Criteria:

    • Known histological transformation from indolent NHL to DLBCL

    • History of central nervous system lymphoma (either primary or metastatic)

    • Prior treatment with the following:

    1. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).

    2. 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ja-Aichi Anjo Kosei Hospital Anjo Japan 446-8602
    2 University of Fukui Hospital Fukui Japan 910-1193
    3 Jcho Kyushu Hospital Fukuoka Japan 806-8501
    4 National Hospital Organization Kyushu Cancer Center Fukuoka Japan 811-1395
    5 Fukushima Medical University Hospital Fukushima Japan 960-1295
    6 Kansai Medical University Hospital Hirakata Japan 573-1191
    7 Hokuyukai Sapporo Hokuyu Hospital Hokkaido Japan 003-0006
    8 Hyogo College of Medicine Hospital Hyogo Japan 663-8501
    9 Nho Mito Medical Center Ibaraki Japan 311-3193
    10 Tokai University Hospital Isehara Japan 259-1193
    11 Jiaikai Imamura General Hospital Kagoshima Japan 890-0064
    12 Kobe City Medical Center General Hospital Kobe Japan 650-0047
    13 University Hospital Kyoto Prefectural University of Medicine Kyoto Japan 602-8566
    14 Nho Matsumoto Medical Center Matsumoto Japan 399-8701
    15 Nho Shikoku Cancer Center Matsuyama Japan 791-0280
    16 Nagano Red Cross Hospital Nagano Japan 380-8582
    17 National Hospital Organization Nagoya Medical Center Nagoya Japan 460-0001
    18 Japanese Red Cross Nagoya Daini Hospital Nagoya Japan 466-8650
    19 Red Cross Nagoya Daini Hospital Nagoya Japan 4668650
    20 Tenri Hospital Nara Japan 632-8552
    21 Miyagi Cancer Center Natori Japan 981-1293
    22 Niigata Cancer Center Hospital Niigata Japan 951-8566
    23 Ogaki Municipal Hospital Ogaki Japan 5038502
    24 Okayama University Hospital Okayama Japan 700-8558
    25 Nho Hokkaido Cancer Center Sapporo Japan 003-0804
    26 Tohoku University Hospital Sendai-shi Japan 980-8574
    27 Shizuoka Cancer Center Shizuoka Japan 411-8777
    28 Nippon Medical School Hospital Tokyo Japan 113-8603
    29 Yokohama Municipal Citizens Hospital Yokohama Japan 221-0855
    30 Yokohama City University Medical Center Yokohama Japan 232-0024

    Sponsors and Collaborators

    • Incyte Biosciences Japan GK

    Investigators

    • Study Director: Incyte Medical Monitor, Incyte Biosciences Japan GK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Biosciences Japan GK
    ClinicalTrials.gov Identifier:
    NCT04434937
    Other Study ID Numbers:
    • INCB 50465-213
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Biosciences Japan GK
    Follicular Lymphoma
    Parsaclisib
    PI3Kδ Inhibitor
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular

    Study Results

    No Results Posted as of Jul 29, 2022