A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Incyte

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: Parsaclisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03144674

INCB 50465-204 (CITADEL-204)

Parsaclisib (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, aged 18 or older (except in South Korea, aged 19 or older).
• Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
• Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
• Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
• Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion criteria

• Evidence of diffuse large B-cell transformation.
• History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
• Prior treatment with idelalisib, other selective 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 the first dose of study treatment.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Cohort 1- Closed to Further enrollment

Experimental group

Description:

Participants who have received prior ibrutinib.

Treatment:

Drug: Parsaclisib

Cohort 2

Experimental group

Description:

Participants who have not received a prior BTK inhibitor.

Treatment:

Drug: Parsaclisib