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

Incyte

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: Parsaclisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02998476

2016-002205-19 (EudraCT Number)

Parsaclisib (Other Identifier)

INCB 50465-202/CITADEL-202

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Group A Parsaclisib (no prior BTK inhibitor)

Experimental group

Description:

Parsaclisib in subjects who were not previously treated with a BTK inhibitor.

Treatment:

Drug: Parsaclisib

Group B Parsaclisib (prior BTK inhibitor)

Experimental group

Description:

Parsaclisib in subjects who were previously treated with a BTK inhibitor.

Treatment:

Drug: Parsaclisib