A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02760485
Collaborator
(none)
33
21
1
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Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 29, 2016
Anticipated Primary Completion Date :
Oct 27, 2022
Anticipated Study Completion Date :
Oct 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: itacitinib + ibrutinib

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 Names:
  • INCB039110
  • Drug: ibrutinib

    Outcome Measures

    Primary Outcome Measures

    1. Phase 1: Safety and tolerability as assessed by adverse events and changes in clinical and laboratory assessments [Screening through 35 days after end of treatment, estimated to be 12 months]

    2. Phase 2: Efficacy as assessed by objective response rate (ORR) [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.

    Secondary Outcome Measures

    1. Phase 1: Efficacy as assessed by objective response rate (ORR) [Screening through 16 weeks]

      Defined as percentage of subjects achieving a complete response (CR) or partial response (PR) based on radiographic assessment.

    2. Phase 2: Efficacy as assessed by duration of response (DOR) [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.

    3. Phase 2: Durable response rate [Screening through 16 weeks]

      Durable response rate is defined as the percentage of subjects achieving a CR or PR for > 16 weeks.

    4. Phase 2: Efficacy as assessed by progression-free survival (PFS) [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.

    5. Phase 2: Efficacy as assessed by overall survival (OS) [Every 12 weeks, estimated to be 12 months]

      Defined as date of enrollment until death due to any cause.

    6. Phase 2: Number of treatment-emergent adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    2 City of Hope National Medical Center Duarte California United States 91010
    3 Pacific Shores Medical Group Long Beach California United States 90813
    4 LAC-USC Medical Center/Kenneth Norris Jr Cancer Hospital Los Angeles California United States 90033
    5 Moores UC San Diego Cancer Center San Diego California United States 92093
    6 Mount Sinai Comprehensive Cancer Center Miami Beach Florida United States 33140
    7 Georgia Regents Research Institute Augusta Georgia United States 30912
    8 University of Maryland Cancer Center Baltimore Maryland United States 21201
    9 University of Michigan Cancer Center Ann Arbor Michigan United States 48109
    10 Michigan State University Breslin Cancer Center Lansing Michigan United States 48910
    11 St Vincent Frontier Cancer Center Billings Montana United States 59102
    12 Comprehensive Cancer Center of Nevada Las Vegas Nevada United States 89169
    13 Regional Cancer Center Associates, LLC Little Silver New Jersey United States 07739
    14 Roswell Cancer Center Buffalo New York United States 14263
    15 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    16 Toledo Clinic Cancer Centers Toledo Ohio United States 43623
    17 Tulsa Cancer Center Tulsa Oklahoma United States 74146
    18 Geisinger Medical Center Danville Pennsylvania United States 17822
    19 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    20 Houston Methodist Cancer Center Houston Texas United States 77030
    21 Northwest Medical Specialists & Research Institute Puyallup Washington United States 98373

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Peter Langmuir, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02760485
    Other Study ID Numbers:
    • INCB 39110-206
    First Posted:
    May 3, 2016
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022

    Study Results

    No Results Posted as of Jun 29, 2022