NCT03235544

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT03235544

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

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

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).

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Parsaclisib
- Description: Parsaclisib tablets administered orally with water and without regard to food.
- Arm Group Labels: Cohort 1: Treatment A (Exposed to Ibrutinib), Cohort 1: Treatment B (Exposed to Ibrutinib), Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve), Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)

Sponsor

Incyte Corporation