A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor ((CITADEL-205))

Incyte

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: Parsaclisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235544

2017-003148-19 (EudraCT Number)

Parsaclisib (Other Identifier)

INCB 50465-205 (CITADEL-205)

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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162 participants in 4 patient groups

Cohort 1: Treatment A (Exposed to Ibrutinib)

Experimental group

Description:

Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

Treatment:

Drug: Parsaclisib

Cohort 1: Treatment B (Exposed to Ibrutinib)

Experimental group

Description:

Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

Treatment:

Drug: Parsaclisib

Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)

Experimental group

Description:

Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.

Treatment:

Drug: Parsaclisib

Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)

Experimental group

Description:

Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group.

Treatment:

Drug: Parsaclisib