Phase 2
Completed N=60
A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Source: ClinicalTrials.gov NCT02998476 ↗Enrolled (actual)
60
Serious AEs
68.3%
Results posted
Apr 2020
Primary outcomePrimary: Objective Response Rate Based on Lugano Classification Criteria in Group A — 25.5 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate Based on Lugano Classification Criteria in Group A |
25.5 | — |
| SECONDARY Duration of Response in Group A |
6.2 | — |
| SECONDARY Progression-free Survival in Group A |
2.2 | — |
| SECONDARY Overall Survival (OS) in Group A |
7.0 | — |
| SECONDARY Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B |
50; 4 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02998476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.