An open-label study of INCB050465 in patients with relapsed or refractory Mantle Cell Lymphoma with or without prior exposure to a BTK inhibitor.

Phase 1

• Conditions: Mantle Cell Lymphoma; MedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003148-19-CZ
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Subjects with pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or t(11;14), who have had at least 1 but no more than 3 prior systemic treatment regimens.
• Men and women, aged 18 or older
• Documented failure to achieve at least PR with or documented disease progression after the most recent treatment regimen.
• 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 CT or magnetic resonance imaging (MRI).
• Eastern Cooperative Oncology Group (ECOG) performance status of = 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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

• History of central nervous system lymphoma (either primary or metastatic).
• Prior treatment with idelalisib, other selective phosphoinositide 3-kinase (PI3K) d inhibitors, or a pan-PI3K inhibitor.
• Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of 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