Clinical trial

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

Name

INCB 39110-206

Description

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)

Trial arms

Trial start

2016-12-29

Estimated PCD

2022-06-06

Trial end

2022-06-06

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

itacitinib + ibrutinib

Other names:

INCB039110

ibrutinib

Arms:

itacitinib + ibrutinib

Size

Primary endpoint

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

up to 285 days

Phase 1: Number of Participants With Any Grade 3 or Higher TEAE

up to 285 days

Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)

up to Day 28

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)

up to 1538 days

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}

Updated at

2023-06-15

1 organization

2 products

1 indication

Product

Indication

Organization

Product