Phase 2
N=161
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03235544 ↗Enrolled (actual)
161
Serious AEs
50.9%
Results posted
Feb 2022
Primary outcome: Primary: Objective Response Rate (ORR) — 8.3; 39.0; 64.5; 71.4 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
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
8.3; 39.0; 64.5; 71.4 | — |
| SECONDARY Duration of Response (DOR) |
NA; 3.20; 17.45; 13.01 | — |
| SECONDARY Complete Response Rate (CRR) |
0.0; 2.4; 22.6; 15.6 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.94; 3.68; 8.11; 13.83 | — |
| SECONDARY Overall Survival (OS) |
10.91; 11.01; 33.48; 45.86 | — |
| SECONDARY Best Percent Change From Baseline in Target Lesion Size |
-19.82; -9.51; -64.65; -67.54 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
83.3; 90.2; 93.5; 92.2; 41.7; 48.8 | — |
Summary
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Eligibility Criteria
Inclusion Criteria
- Men and women, aged 18 years or older.
- Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Exclusion Criteria
- 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.
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.
- Active graft-versus-host disease.
- Liver 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 (NCT03235544). 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.