Description:
The purpose of this study is to assess the objective response rate of parsaclisib treatment
in subjects with relapsed or refractory follicular lymphoma.
Title
- Brief Title: An Open-Label Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
- Official Title: A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
Clinical Trial IDs
- ORG STUDY ID:
INCB 50465-203 (CITADEL-203)
- SECONDARY ID:
Parsaclisib
- NCT ID:
NCT03126019
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Parsaclisib | INCB050465 | Group B |
| Parsaclisib | INCB050465 | Group A |
Purpose
The purpose of this study is to assess the objective response rate of parsaclisib treatment
in subjects with relapsed or refractory follicular lymphoma.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Group A | Experimental | Parsaclisib once daily (QD) for 8 weeks followed by Parsaclisib once weekly | |
| Group B | Experimental | Parsaclisib QD | |
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell NHL (follicular
lymphoma) 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 or
magnetic resonance imaging.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
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 PI3Kδ 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 study treatment administration.
- Active graft-versus-host disease.
- Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be
eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody
will be eligible if they are negative for HCV-RNA.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Objective response rate with parsaclisib based on Lugano classification response criteria |
| Time Frame: | Weeks 8, 16, and 24, then every 12 weeks through Week 96, and then every 24 Weeks thereafter until disease progression, up to approximately 12 months. |
| Safety Issue: | |
| Description: | Defined as the percentage of subjects with a complete response (CR) or partial response (PR) as determined by an independent review committee. |
Secondary Outcome Measures
| Measure: | Complete response rate with parsaclisib based on Lugano classification response criteria |
| Time Frame: | Up to approximately 12 months per subject |
| Safety Issue: | |
| Description: | Defined as the percentage of subjects with a CR as determined by an independent review committee. |
| Measure: | Duration of response |
| Time Frame: | Up to approximately 24 months per subject |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Progression-free survival with parsaclisib |
| Time Frame: | Up to approximately 24 months per subject (approximately 12 months for median) |
| Safety Issue: | |
| Description: | Defined as the time from the date of first dose of study treatment until the earliest date of disease progression or death from any cause. |
| Measure: | Overall survival with parsaclisib |
| Time Frame: | Up to approximately 24 months per subject |
| Safety Issue: | |
| Description: | Defined as the time from the date of first dose of study treatment until death from any cause. |
| Measure: | Safety and tolerability of parsaclisib measured by adverse events (AEs) |
| Time Frame: | Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject |
| Safety Issue: | |
| Description: | Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Follicular lymphoma
- non-Hodgkin lymphoma (NHL)
- phosphatidylinositol 3-kinase (PI3K) δ inhibitor
Last Updated
October 23, 2020
