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A Phase 2 Safety and Efficacy Study of INCB050465 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
Results First Posted : April 24, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Parsaclisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : February 22, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Group A Parsaclisib (no prior BTK inhibitor)
Parsaclisib in subjects who were not previously treated with a BTK inhibitor.
Drug: Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Other Name: INCB050465

Experimental: Group B Parsaclisib (prior BTK inhibitor)
Parsaclisib in subjects who were previously treated with a BTK inhibitor.
Drug: Parsaclisib
Parsaclisib once daily for 8 weeks followed by once weekly
Other Name: INCB050465




Primary Outcome Measures :
  1. Objective Response Rate Based on Lugano Classification Criteria in Group A [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 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) as determined by IRC.


Secondary Outcome Measures :
  1. Duration of Response in Group A [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 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 as determined by IRC.

  2. Progression-free Survival in Group A [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 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 as provided by an IRC.

  3. Overall Survival (OS) in Group A [ Time Frame: From first dose of study drug until death by any cause; up to 26 months ]
    Defined as the time from the date of the first dose of study drug until death by any cause.

  4. Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B [ Time Frame: Screening through 35 days after end of treatment, up to 42 months ]
    A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.



Information from the National Library of Medicine

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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:

  • 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.

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): NCT02998476


Locations
Show Show 62 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Claudia Corrado, MD Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol  [PDF] November 5, 2019
Statistical Analysis Plan  [PDF] March 22, 2018

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02998476    
Other Study ID Numbers: INCB 50465-202/CITADEL-202
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: December 20, 2016    Key Record Dates
Results First Posted: April 24, 2020
Last Update Posted: September 18, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Diffuse large B-cell lymphoma
relapsed
refractory
non-Hodgkin lymphoma
phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor
Bruton's tyrosine kinase (BTK)
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin