Marginal Zone Lymphoma MedDRA version: 20.0 Level: PT Classification code 10076596 Term: Marginal zone 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: • Men and women, aged 18 or older • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures > 1.5 cm in the longest transverse diameter (LDi) and = 1.0 cm in the longest perpendicular diameter as assessed by CT or magnetic resonance imaging (MRI). -Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed. • Subjects must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue. -Subjects with splenic MZL who do not have a tumor to biopsy or archival tumor tissue are eligible for participation provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained since completion of last therapy and within two years before the date of the first dose of study treatment. • Eastern Cooperative Oncology Group (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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: • Evidence of diffuse large B-cell transformation. • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. • Prior treatment with idelalisib, other selective PI3Kd 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 the first dose of study treatment. • Active graft versus host disease. • Liver disease: - Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with marginal zone lymphoma that is relapsed or refractory after at least 1 systemic treatment regimen.;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: Throughout the study | — |
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 • OS 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
Australia, Belgium, Canada, Denmark, France, Germany, Israel, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Incyte Corporation
Outcome results
None listed