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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04434937
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences Japan GK )

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
Lymphoma Drug: parsaclisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 30, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: INCB050465




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434937


Contacts
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Contact: Incyte Biosciences Japan GK Development Operations Call Center (JPN) +81 3-3507-5795 japan_clinicaltrials@incyte.com

Locations
Show Show 30 study locations
Sponsors and Collaborators
Incyte Biosciences Japan GK
Investigators
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Study Director: Incyte Medical Monitor Incyte Biosciences Japan GK
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Responsible Party: Incyte Biosciences Japan GK
ClinicalTrials.gov Identifier: NCT04434937    
Other Study ID Numbers: INCB 50465-213
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation ( Incyte Biosciences Japan GK ):
Follicular Lymphoma
Parsaclisib
PI3Kδ Inhibitor
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin