A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02760485|
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : November 15, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: itacitinib Drug: ibrutinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 29, 2016|
|Actual Primary Completion Date :||June 6, 2022|
|Actual Study Completion Date :||June 6, 2022|
|Experimental: itacitinib + ibrutinib||
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
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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
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): NCT02760485
|Study Director:||Peter Langmuir, MD||Incyte Corporation|
|Responsible Party:||Incyte Corporation|
|Other Study ID Numbers:||
|First Posted:||May 3, 2016 Key Record Dates|
|Last Update Posted:||November 15, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency.
Statistical Analysis Plan (SAP)
|Time Frame:||Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.|
|Access Criteria:||Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.|
Diffuse large B-cell lymphoma
Relapsed Diffuse large B-cell lymphoma
Refractory Diffuse large B-cell lymphoma
activated B cell
germinal center B-cell
Bruton's tyrosine kinase (BTK) inhibitor
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immune System Diseases