A phase 2, multicenter, international, open-label, safety and efficacy study of INCB050465 in patients with relapsed or refractory diffuse large B-cell lymphoma.

A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma - CITADEL-202

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002205-19-FR

Enrollment

120

Registered

2017-05-04

Start date

2017-07-05

Completion date

Unknown

Last updated

2021-04-12

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

Conditions

Diffuse large B-cell lymphoma MedDRA version: 20.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Code: INCB050465 5 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: • Men and women, aged 18 years or older. • Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens (eg, an anti-CD20 antibody, an anti-CD20 antibody with or without chemotherapy, or chemotherapy alone) and ineligible for high-dose chemotherapy supported by autologous stem cell transplant. • Must have = 1 measurable (= 2 cm in longest dimension) or = 1 measurable extranodal lesion (> 1 cm in longest dimension) lesion on computed tomography (CT) scan or magnetic resonance imaging (MRI). • Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy. • Eastern Cooperative Oncology Group 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 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54

Exclusion criteria

Exclusion criteria: • Primary mediastinal (thymic) large B-cell lymphoma. • Known brain or central nervous system metastases or history of uncontrolled seizures. • Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months. • Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. • Prior treatment with the following: - Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) d inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib). - Group B: Prior treatment with a selective PI3Kd inhibitor (eg, idelalisib) or a pan-PI3K inhibitor.

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 DLBCL who were not previously treated with a BTK inhibitor (group A).;Secondary Objective: • To assess the duration of response (DOR) in subjects who were not previously treated with a BTK inhibitor (group A) • To assess progression-free survival (PFS) in group A • To assess overall survival (OS) in group A • To characterize the safety of INCB050465;Primary end point(s): ORR in Group A, defined as the percentage of subjects with a complete response/complete metabolic response (CR/CMR) or partial response/partial metabolic response (PR/PMR) as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an Independent Review Committee.;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

Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory DLBCL who were not previously treated with a BTK inhibitor (group A).;Secondary Objective: • To assess the duration of response (DOR) in subjects who were not previously treated with a BTK inhibitor (group A) • To assess progression-free survival (PFS) in group A • To assess overall survival (OS) in group A • To characterize the safety of INCB050465;Primary end point(s): ORR in Group A, defined as the percentage of subjects with a complete response/complete metabolic response (CR/CMR) or partial response/partial metabolic response (PR/PMR) as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an Independent Review Committee.;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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Secondary

Measure	Time frame
Secondary end point(s): • DOR in Group A, defined as the time from first documented evidence of CR/CMR or PR/PMR 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 in Group A, defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. • OS in Group A, defined as the time from the date of the first dose of study drug until death by any cause. • Safety as measured by clinical assessments, including vital signs and physical examinations, 12-lead electrocardiograms (ECG), 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): • DOR in Group A, defined as the time from first documented evidence of CR/CMR or PR/PMR 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 in Group A, defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. • OS in Group A, defined as the time from the date of the first dose of study drug until death by any cause. • Safety as measured by clinical assessments, including vital signs and physical examinations, 12-lead electrocardiograms (ECG), 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, Belgium, Canada, Czech Republic, France, Korea, Republic of, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Incyte Corporation

RA@incyte.com+13024252734

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026