A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kd Inhibitor, in Relapsed or Refractory Follicular Lymphoma(CITADEL-203)

Phase 1

• Conditions: Follicular Lymphoma; MedDRA version: 21.1Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001624-22-IT
• Lead Sponsor: INCYTE CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Aged 18 years or older
• Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) 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 (CT) or magnetic resonance imaging (MRI).
• Subjects 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.
• ECOG performance status 0 to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72

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 (PI3K) d 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 randomization.
• Active graft-versus-host disease.
• Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti–hepatitis B core antibody. Subjects who have positive anti-HBs as the only evidence of prior exposure may participate in the study provided that there is both 1) no known history of HBV infection and 2) verified receipt of hepatitis B vaccine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified