Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    INCB50465-203
Previous Study | Return to List | Next Study

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

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: NCT03126019
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Group A
Parsaclisib once daily (QD) for 8 weeks followed by Parsaclisib once weekly
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

Experimental: Group B
Parsaclisib QD
Drug: Parsaclisib
Parsaclisib at the protocol-defined starting dose for 8 weeks, followed by Parsaclisib at the protocol-defined dose QD
Other Name: INCB050465




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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:

  • 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.

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): NCT03126019


Contacts
Layout table for location contacts
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

  Show 80 Study Locations
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: NCT03126019     History of Changes
Other Study ID Numbers: INCB 50465-203 (CITADEL-203)
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Follicular lymphoma
non-Hodgkin lymphoma (NHL)
phosphatidylinositol 3-kinase (PI3K) δ inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin