Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2 Safety and Efficacy Study of Parsaclisib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02998476
Recruitment Status : Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date March 21, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
Objective response rate based on Lugano Classification criteria [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to 42 months ]
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02998476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
  • Median duration of response [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter, up to 42 months ]
    Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response.
  • Median progression-free survival [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter, up to 42 months ]
    Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment.
  • Overall survival (OS) [ Time Frame: From randomization every 12 weeks until death due to any cause; up to 42 months ]
  • Safety as assessed by percentage of subjects with adverse events [ Time Frame: Screening through 35 days after end of treatment, up to 42 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Safety and Efficacy Study of Parsaclisib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Official Title  ICMJE A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of Parsaclisib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Brief Summary The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Drug: Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Other Name: INCB050465
Study Arms  ICMJE
  • Experimental: Group A Parsaclisib (no prior BTK inhibitor)
    Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
    Intervention: Drug: Parsaclisib
  • Experimental: Group B Parsaclisib (prior BTK inhibitor)
    Parsaclisib in subjects who were previously treated with a BTK inhibitor.
    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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 5, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2016)
120
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eligible 19 years and older in South Korea
  • Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
  • Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
  • Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
  • Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

  • Primary mediastinal (thymic) large B-cell lymphoma.
  • Known brain or central nervous system metastases or history of uncontrolled seizures.
  • Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
  • Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
  • Prior treatment with the following:

    • Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
    • Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   France,   Korea, Republic of,   Poland,   Spain,   United States
Removed Location Countries Italy,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02998476
Other Study ID Numbers  ICMJE INCB 50465-202/CITADEL-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 March 2019

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