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

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

Layout table for study information
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 Parsaclisib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 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 [ 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall survival (OS) [ Time Frame: From randomization every 12 weeks until death due to any cause; up to 42 months ]
  4. Safety as assessed by percentage of subjects with adverse events [ Time Frame: Screening through 35 days after end of treatment, up to 42 months ]


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.


Layout table for eligibility information
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


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0002
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Indiana
Indiana BMT
Beech Grove, Indiana, United States, 46107
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
United States, Nebraska
CHI Health - St. Francis Medical Center
Grand Island, Nebraska, United States, 68802
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901-1914
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
Australia, New South Wales
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Ballarat Base Hospital
Ballarat, Victoria, Australia, 3350
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Belgium
ZNA Stuivenberg
Antwerpen, Belgium, 2060
UZ Leuven
Leuven, Belgium, 3000
AZ Delta
Roeselare, Belgium, 8800
Canada, Ontario
LHSC - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Czechia
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czechia, 500 05
France
Centre Antoine Lacassagne
Nice cedex 02, Alpes Maritimes, France, 06189
Centre Francois Baclesse
Caen Cedex 05, Calvados, France, 14076
CHU Dijon - Hopital du Bocage
Dijon cedex, Cote dÝOr, France, 21079
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, Isere, France, 38043
Centre Hospitalier d'Angers
Angers Cedex 01, Maine Et Loire, France, 49033
CHU de Nancy - Hôpital de Brabois Adultes
Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54511
Centre Hospitalier Lyon Sud
Pierre Bénite, Rhone, France, 69495
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Malopolskie Centrum Medyczne s.c.
Krakow, Poland, 30-510
Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Sponsors and Collaborators
Incyte Corporation
Investigators
Layout table for investigator information
Study Director: Claudia Corrado, MD Incyte Corporation

Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02998476     History of Changes
Other Study ID Numbers: INCB 50465-202/CITADEL-202
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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:
Layout table for MeSH terms
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