Phase 2
N=126
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03126019 ↗Enrolled (actual)
126
Serious AEs
53.2%
Results posted
Feb 2022
Primary outcome: Primary: Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria — 65.2; 77.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Parsaclisib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria |
65.2; 77.7 | — |
| SECONDARY Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria |
17.4; 22.3 | — |
| SECONDARY Duration of Response (DOR) |
14.06; 14.72 | — |
| SECONDARY Progression-free Survival (PFS) With Parsaclisib |
19.32; 14.03 | — |
| SECONDARY Overall Survival (OS) With Parsaclisib |
NA; NA | — |
| SECONDARY Best Percent Change From Baseline in Target Lesion Size |
-72.90; -72.77 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
100.0; 99.0; 52.2; 53.4 | — |
Summary
The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (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 phosphatidylinositol 3-kinase delta (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.
- Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).
Data sourced from ClinicalTrials.gov (NCT03126019). 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.