Mantle Cell Lymphoma MedDRA version: 20.0 Level: PT Classification code 10061275 Term: Mantle cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with mantle cell lymphoma (MCL) that is relapsed or refractory after at least 1 but no more than 3 prior systemic treatment regimens.;Secondary Objective: • To assess duration of response (DOR). • To assess complete response rate (CRR). • To assess progression-free survival (PFS). • To assess overall survival (OS). • To assess the best percentage change in target lesion size. • 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 determined by independent review committee (IRC) assessment of response according to computed tomography (CT)-based response criteria for lymphomas.;Timepoint(s) of evaluation of this end point: Response data will be analyzed when all subjects in the respective cohort have received at least 1 postbaseline disease assessment or have progressed, withdrawn from the study, or died. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • DOR defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among subjects who achieve an objective response, as determined by radiographic disease assessment provided by an IRC. • CRR defined as the percentage of subjects with a CR as defined by response criteria for lymphomas as determined by an IRC. • PFS defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. • Overall survival defined as the time from the date of the first dose of study treatment until death from any cause. • Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of diameters of all target lesion sizes. • Safety measured by adverse events (AEs), 12-lead electrocardiograms (ECGs), chemistry and hematology laboratory values, vital signs, and physical examinations.;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Incyte Corporation
Outcome results
None listed