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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 : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

May 5, 2017
May 9, 2017
October 5, 2018
June 27, 2017
March 2020   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03144674 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
Drug: INCB050465
INCB050465 at the protocol-defined dose.
  • Experimental: Cohort 1
    Participants who have received prior ibrutinib.
    Intervention: Drug: INCB050465
  • Experimental: Cohort 2
    Participants who have not received a prior BTK inhibitor.
    Intervention: Drug: INCB050465
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Same as current
March 2022
March 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
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
Australia,   Belgium,   Denmark,   France,   Germany,   Israel,   Italy,   Poland,   Spain,   United Kingdom,   United States
 
 
NCT03144674
INCB 50465-204 (CITADEL-204)
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Ricardo Espinola, MD Incyte Corporation
Incyte Corporation
October 2018

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