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A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

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ClinicalTrials.gov Identifier: NCT03144674
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of two INCB050465 treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: INCB050465 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Cohort 1
Participants who have received prior ibrutinib.
Drug: INCB050465
INCB050465 at the protocol-defined dose.

Experimental: Cohort 2
Participants who have not received a prior BTK inhibitor.
Drug: INCB050465
INCB050465 at the protocol-defined dose.




Primary Outcome Measures :
  1. Objective response rate based on Lugano Classification criteria [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by independent review committee (IRC) assessment.


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response.

  2. Complete response rate based on Lugano Classification criteria. [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the percentage of participants with a CR as determined by an IRC.

  3. Progression-free survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression or death from any cause.

  4. Overall survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until death from any cause.

  5. Best percentage change from baseline in target lesion size [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Target lesion size is measured by the sum of the product of diameters of all target lesion sizes.

  6. Safety of INCB050465 as measured by adverse events (AEs) [ Time Frame: Baseline through 30-35 days after end of treatment, up to approximately 15 months per participant. ]
    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.



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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:

  • Men and women, aged 18 or older (except in South Korea, aged 19 or older).
  • Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
  • Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
  • Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

  • Evidence of diffuse large B-cell transformation.
  • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
  • Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
  • Active graft versus host disease.
  • Liver disease: Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation.

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): NCT03144674


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

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Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Ricardo Espinola, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03144674     History of Changes
Other Study ID Numbers: INCB 50465-204 (CITADEL-204)
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Marginal zone lymphoma
phosphatidylinositol 3-kinase (PI3K)δ inhibitor
indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin