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

Incyte

Status and phase

Completed

Phase 2

Phase 1

Conditions

Lymphoma

Treatments

Drug: ibrutinib

Drug: itacitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02760485

INCB 39110-206

Details and patient eligibility

About

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)

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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