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

A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kd Inhibitor, in Relapsed or Refractory Follicular Lymphoma - CITADEL-203

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001624-22-GB

Enrollment

100

Registered

2017-10-10

Start date

2018-04-12

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma MedDRA version: 20.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864

Interventions

Product Code: INCB050465 1 mg tablet Pharmaceutical Form: Tablet INN or Proposed INN: not yet assigned Current Sponsor code: INCB050465 Other descriptive name: INCB050465 HYDROCHLORIDE Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL).;Secondary Objective: • To assess INCB050465 with idelalisib for complete response rate (CRR). • To assess the duration of response (DOR). • To assess progression-free survival (PFS). • To assess overall survival (OS). • To assess 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 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 ITT population have received at least 1 postbaseline disease assessment or have progressed, withdrawn from the study, or died, and no later than when the last subject reaches his or her third postbaseline disease assessment.	—

Measure

Time frame

Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL).;Secondary Objective: • To assess INCB050465 with idelalisib for complete response rate (CRR). • To assess the duration of response (DOR). • To assess progression-free survival (PFS). • To assess overall survival (OS). • To assess 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 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 ITT population have received at least 1 postbaseline disease assessment or have progressed, withdrawn from the study, or died, and no later than when the last subject reaches his or her third postbaseline disease assessment.

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Secondary

Measure	Time frame
Secondary end point(s): • CRR defined as the percentage of subjects with a CR as defined by revised response criteria for lymphomas, as determined by an IRC. • 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. • PFS defined as the time from 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 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 the diameters of all target lesion sizes. • Safety measured by clinical assessments, including vital signs and physical examinations, 12-lead electrocardiograms (ECGs), chemistry and hematology laboratory values, and adverse events (AEs).;Timepoint(s) of evaluation of this end point: Up to 2 years after the first dose is administered to the last subject enrolled	—

Measure

Time frame

Secondary end point(s): • CRR defined as the percentage of subjects with a CR as defined by revised response criteria for lymphomas, as determined by an IRC. • 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. • PFS defined as the time from 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 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 the diameters of all target lesion sizes. • Safety measured by clinical assessments, including vital signs and physical examinations, 12-lead electrocardiograms (ECGs), chemistry and hematology laboratory values, and adverse events (AEs).;Timepoint(s) of evaluation of this end point: Up to 2 years after the first dose is administered to the last subject enrolled

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Countries

Australia, Canada, Czech Republic, Denmark, Germany, Hungary, Israel, Italy, Poland, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Incyte Corporation

RA@incyte.com+13024986700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 14, 2026