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Trial record 1 of 1 for:    02760485
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A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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: NCT02760485
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 3, 2016
Last Update Posted Date November 15, 2021
Actual Study Start Date  ICMJE December 29, 2016
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Phase 1: Safety and tolerability as assessed by adverse events and changes in clinical and laboratory assessments [ Time Frame: Screening through 35 days after end of treatment, estimated to be 12 months ]
  • Phase 2: Efficacy as assessed by objective response rate (ORR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, estimated to be 12 months ]
    Defined as percentage of subjects achieving a complete response (CR) or partial response (PR) based on radiographic assessment.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Phase 1: Safety and tolerability as assessed by adverse events and changes in clinical and laboratory assessments [ Time Frame: Screening through 35 days after end of treatment, up to 6 months ]
  • Phase 2: Efficacy as assessed by objective response rate (ORR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ]
    Defined as percentage of subjects achieving a complete or partial response based on radiographic assessment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Phase 1: Efficacy as assessed by objective response rate (ORR) [ Time Frame: Screening through 16 weeks ]
    Defined as percentage of subjects achieving a complete response (CR) or partial response (PR) based on radiographic assessment.
  • Phase 2: Efficacy as assessed by duration of response (DOR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, estimated to be 12 months ]
    Defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
  • Phase 2: Durable response rate [ Time Frame: Screening through 16 weeks ]
    Durable response rate is defined as the percentage of subjects achieving a CR or PR for > 16 weeks.
  • Phase 2: Efficacy as assessed by progression-free survival (PFS) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, estimated to be 12 months ]
    Defined as date of enrollment to earliest date of disease progression based on radiographic assessment or death due to any cause.
  • Phase 2: Efficacy as assessed by overall survival (OS) [ Time Frame: Every 12 weeks, estimated to be 12 months ]
    Defined as date of enrollment until death due to any cause.
  • Phase 2: Number of treatment-emergent adverse events [ Time Frame: Screening through 35 days after end of treatment, estimated to be 12 months ]
    Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Efficacy as assessed by duration of response (DOR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ]
    Defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
  • Efficacy as assessed by progression-free survival (PFS) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ]
    Defined as date of enrollment to earliest date of disease progression based on radiographic assessment or death due to any cause.
  • Efficacy as assessed by overall survival (OS) [ Time Frame: Every 12 weeks, up to 6 months ]
    Defined as date of enrollment until death due to any cause.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official Title  ICMJE An Open-Label Phase 1/2 Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Brief Summary The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: itacitinib
    Phase 1 will evaluate itacitinib at the protocol-specified starting dose, with a possible increase or decrease depending on tolerability. Phase 2 will evaluate the recommended dose determined in Phase 1.
    Other Name: INCB039110
  • Drug: ibrutinib
Study Arms  ICMJE Experimental: itacitinib + ibrutinib
Interventions:
  • Drug: itacitinib
  • Drug: ibrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 22, 2019)
33
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2016)
78
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented diagnosis of DLBCL.

    • Phase 1: any DLBCL subtype.
    • Phase 2: activated B-cell or unclassifiable subtypes confirmed by immunohistochemistry using the Hans algorithm
  • Relapsed or refractory DLBCL, defined as having received at least 1 but no more than 3 prior treatment regimens and ineligible for high-dose chemotherapy/autologous stem cell transplant.
  • Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano Classification. Fluorodeoxyglucose-avid disease is defined as disease with a 5-point scale score of 4 or 5.
  • Archived tumor tissue (block or 15-20 unstained slides) available, or be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy (or, in less accessible lymph nodes, 4 to 8 core biopsies).
  • At least 1 measurable (≥ 2 cm in longest dimension) lesion on CT scan or magnetic resonance imaging (MRI).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

  • Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or mucosa-associated lymphoid tissue lymphoma).
  • Primary mediastinal (thymic) large B-cell lymphoma.
  • Known central nervous system lymphoma (either primary or metastatic).
  • Allogeneic stem cell transplant within the previous 6 months, or active graft versus host disease following allogeneic transplant.
  • Use of immunosuppressive therapy within 28 days of starting study treatment. Immunosuppressive therapy includes but is not limited to cyclosporine A, tacrolimus, or high-dose corticosteroids. Subjects receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7 days of initiating study treatment.
  • Prior or concurrent therapy with a Janus kinase inhibitor or Bruton's tyrosine kinase inhibitor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02760485
Other Study ID Numbers  ICMJE INCB 39110-206
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fitzroy Dawkins, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date November 2021

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