A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

• ClinicalTrials.gov Identifier: NCT02998476
• Recruitment Status: Active, not recruiting
• First Posted: December 20, 2016
• Last Update Posted: September 13, 2019
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Study Description

Brief Summary:

The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Condition or disease	Intervention/treatment	Phase
Lymphoma	Drug: Parsaclisib	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: December 2016
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: July 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A Parsaclisib (no prior BTK inhibitor); Parsaclisib in subjects who were not previously treated with a BTK inhibitor.	Drug: Parsaclisib; Parsaclisib once daily for 8 weeks followed by once weekly; Other Name: INCB050465
Experimental: Group B Parsaclisib (prior BTK inhibitor); Parsaclisib in subjects who were previously treated with a BTK inhibitor.	Drug: Parsaclisib; Parsaclisib once daily for 8 weeks followed by once weekly; Other Name: INCB050465

Outcome Measures

Primary Outcome Measures :

1. Objective response rate based on Lugano Classification criteria [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to 42 months ]
   Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014).

Secondary Outcome Measures :

1. Median duration of response [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter, up to 42 months ]
   Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response.
2. Median progression-free survival [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter, up to 42 months ]
   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.
3. Overall survival (OS) [ Time Frame: From randomization every 12 weeks until death due to any cause; up to 42 months ]
4. Safety as assessed by percentage of subjects with adverse events [ Time Frame: Screening through 35 days after end of treatment, up to 42 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Eligible 19 years and older in South Korea
• Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
• Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) 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.

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) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
  • Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.

Contacts and Locations

  Show 31 Study Locations

Sponsors and Collaborators

Incyte Corporation

Investigators

• Study Director: Claudia Corrado, MD; Incyte Corporation

More Information

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT02998476 History of Changes
• Other Study ID Numbers: INCB 50465-202/CITADEL-202; Parsaclisib ( Other Identifier: Incyte Corporation )
• First Posted: December 20, 2016
• Last Update Posted: September 13, 2019
• Last Verified: September 2019

Keywords provided by Incyte Corporation:

Diffuse large B-cell lymphoma; relapsed; refractory; non-Hodgkin lymphoma; phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor; Bruton's tyrosine kinase (BTK)

Additional relevant MeSH terms:

Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin