Phase 2
N=14
A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02760485 ↗Enrolled (actual)
14
Serious AEs
68.8%
Results posted
Jun 2023
Primary outcome: Primary: Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) — 6; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- itacitinib (Drug); ibrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
6; 7 | — |
| PRIMARY Phase 1: Number of Participants With Any Grade 3 or Higher TEAE |
5; 5 | — |
| PRIMARY Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT) |
0; 1 | — |
| PRIMARY Phase 2: Objective Response Rate (ORR), Defined as the Percentage of Participants Achieving Either a Complete Response (CR) or a Partial Response (PR), Per the Modified Lugano Classification for Diffuse Large B-cell Lymphoma (DLBCL) |
26.3 | — |
| SECONDARY Phase 1: ORR, Defined as the Percentage of Participants Achieving Either a CR or a PR, Per the Modified Lugano Classification for DLBCL |
33.3; 57.1 | — |
| SECONDARY Phase 2: Duration of Response (DOR): Time From the First Overall Response Contributing to an Objective Response (CR or PR) to the Earlier of the Participant's Death and the First Overall Response of Progressive Disease, Per the Lugano Classification |
8.80 | — |
| SECONDARY Phase 2: Durable Response Rate (DRR) |
60.0 | — |
| SECONDARY Phase 2: Progression-free Survival (PFS), Defined as the Time From the First Dose to the Earlier Date of Death Due to Any Cause or Disease Progression Determined by Objective Radiographic Disease Assessments |
3.17 | — |
| SECONDARY Phase 2: Number of Participants With Any TEAE |
19 | — |
| SECONDARY Phase 2: Number of Participants With Any Grade 3 or Higher TEAE |
16 | — |
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)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02760485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.