A multicenter, open-label study of INCB050465 in patients with relapsed or refractory follicular lymphoma

Phase 1

• Conditions: Follicular Lymphoma; MedDRA version: 21.1Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001624-22-DK
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-17
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Aged 18 years or older
• Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a.
• Ineligible for hematopoietic stem cell transplant.
• Must have been treated with at least 2 prior systemic therapies.
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures > 1.5 cm in the longest dimension and = 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
• Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
• ECOG performance status 0 to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

Exclusion Criteria

• Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
• History of central nervous system lymphoma (either primary or metastatic).
• Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase (PI3K) d inhibitors, or a pan-PI3K inhibitor.
• Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
• Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
• Active graft-versus-host disease.
• Hepatitis B (HBV) or hepatitis C (HCV) infection: Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA; these subjects should be considered for prophylactic antiviral therapy. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL).<br>;Secondary Objective: • To assess complete response rate (CRR).<br>• To assess the duration of response (DOR).<br>• To assess progression-free survival (PFS).<br>• To assess overall survival (OS).<br>• To assess best percentage change in target lesion size.<br>• To characterize the safety and tolerability of INCB050465.;Primary end point(s): ORR defined as the percentage of subjects with a complete response (CR) or partial response (PR) as defined by revised response criteria for lymphomas, as determined by an Independent Review Committee (IRC).;Timepoint(s) of evaluation of this end point: When all subjects in the full analysis set who have achieved a response (i.e. partial response or complete response) according to the IRC have<br>had approximately 12 months of follow-up from the onset of response.