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An Open-Label Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

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ClinicalTrials.gov Identifier: NCT03126019
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE April 20, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE June 29, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
Objective response rate with parsaclisib based on Lugano classification response criteria [ Time Frame: Weeks 8, 16, and 24, then every 12 weeks through Week 96, and then every 24 Weeks thereafter until disease progression, up to approximately 12 months. ]
Defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by an independent review committee.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
Objective response rate with INCB050465 vs idelalisib based on Lugano classification response criteria [ Time Frame: Weeks 8, 16, and 24, and every 12 weeks thereafter until disease progression, up to approximately 12 months. ]
Defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by an independent review committee.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Complete response rate with parsaclisib based on Lugano classification response criteria [ Time Frame: Up to approximately 12 months per subject ]
    Defined as the percentage of subjects with a CR as determined by an independent review committee.
  • Duration of response [ Time Frame: Up to approximately 24 months per subject ]
    Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among subjects who achieve an objective response.
  • Progression-free survival with parsaclisib [ Time Frame: Up to approximately 24 months per subject (approximately 12 months for median) ]
    Defined as the time from the date of first dose of study treatment until the earliest date of disease progression or death from any cause.
  • Overall survival with parsaclisib [ Time Frame: Up to approximately 36 months per subject ]
    Defined as the time from the date of first dose of study treatment until death from any cause.
  • Safety and tolerability of parsaclisib measured by adverse events (AEs) [ Time Frame: Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject ]
    Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • Complete response rate with INCB050465 vs idelalisib based on Lugano classification response criteria [ Time Frame: Up to approximately 12 months per subject ]
    Defined as the percentage of subjects with a CR as determined by an independent review committee.
  • Duration of response [ Time Frame: Up to approximately 12 months per subject ]
    Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among subjects who achieve an objective response.
  • Progression-free survival with INCB050465 vs idelalisib [ Time Frame: Up to approximately 24 months per subject (approximately 12 months for median) ]
    Defined as the time from the date of randomization until the earliest date of disease progression or death from any cause.
  • Overall survival with INCB050465 vs idelalisib [ Time Frame: Up to approximately 36 months per subject ]
    Defined as the time from the date of randomization until death from any cause.
  • Safety and tolerability of INCB050465 measured by adverse events (AEs) [ Time Frame: Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject ]
    Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Official Title  ICMJE A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Brief Summary The purpose of this study is to assess the objective response rate of parsaclisib treatment in subjects with relapsed or refractory follicular lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: Parsaclisib
    Parsaclisib at the protocol-defined starting dose for 8 weeks, followed by Parsaclisib at the protocol-defined dose QD
    Other Name: INCB050465
  • Drug: Parsaclisib
    Parsaclisib at the protocol-defined starting dose for 8 weeks, followed by Parsaclisib at the protocol-defined dose once weekly
    Other Name: INCB050465
Study Arms  ICMJE
  • Experimental: Group A
    Parsaclisib once daily (QD) for 8 weeks followed by Parsaclisib once weekly
    Intervention: Drug: Parsaclisib
  • Experimental: Group B
    Parsaclisib QD
    Intervention: Drug: Parsaclisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
180
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 years or older.
  • Histologically confirmed, relapsed or refractory, follicular B-cell NHL (follicular lymphoma) Grade 1, 2, and 3a.
  • Ineligible for hematopoietic stem cell transplant.
  • Must have been treated with at least 2 prior systemic therapies.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
  • Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

  • Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
  • History of central nervous system lymphoma (either primary or metastatic).
  • Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
  • Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
  • Active graft-versus-host disease.
  • Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Denmark,   Germany,   Hungary,   Israel,   Italy,   Poland,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03126019
Other Study ID Numbers  ICMJE INCB 50465-203 (CITADEL-203)
Parsaclisib ( Other Identifier: Incyte Corporation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Claudia Corrado, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP