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Trial record 8 of 18 for:    citadel

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

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ClinicalTrials.gov Identifier: NCT03235544
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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

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




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. ]
    Defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by computed tomography (CT)-based response criteria for lymphomas.


Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. ]
    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.

  2. Complete response rate [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. ]
    Defined as the percentage of participants with a CR as defined by response criteria for lymphomas.

  3. Progression-free survival [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. ]
    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: Protocol-defined timepoints throughout the treatment period, up to approximately 26 months. ]
    Defined as the time from the date of the first dose of study treatment until death from any cause.

  5. Best percentage change in target lesion size from baseline [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to approximately 16 months per participant. ]
    Target lesion size measured by the sum of the product of diameters of all target lesion sizes.

  6. Safety and tolerability of parsaclisib as measured by adverse events (AEs) [ Time Frame: Up to approximately 16 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 subject provides informed consent.



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:

  • Men and women, aged 18 years or older.
  • Documented failure to achieve at least PR with, or documented disease progression after, the most recent treatment regimen.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Exclusion Criteria:

  • History of central nervous system lymphoma (either primary or metastatic).
  • 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 first dose of study treatment.
  • Active graft-versus-host disease.
  • Liver 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): NCT03235544


Contacts
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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
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Study Director: Claudia Corrado, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03235544     History of Changes
Other Study ID Numbers: INCB 50465-205 (CITADEL-205)
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.

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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:
Mantle cell lymphoma
non-Hodgkin lymphoma
Bruton's tyrosine kinase (BTK)
phosphatidylinositol 3-kinase (PI3K)
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin