Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

Lymphoma Clinical Trial

Official title:

An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039114
• Other study ID #: INCB 50465-102 (CITADEL-102)
• Secondary ID: Parsaclisib
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2017
• Est. completion date: March 30, 2021

Study information

• Verified date: December 2021
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed FL.
• Documented CD20+ FL.
• Relapsed or refractory to any prior rituximab-containing regimen.
• Previously treated with a maximum of 4 cancer-directed treatment regimens.
• At least 1 measurable lesion > 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging.
• Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

• Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
• History of central nervous system lymphoma (either primary or metastatic).
• Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
• Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
• Prior treatment with a selective PI3Kd inhibitor or a pan PI3K inhibitor.
• Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (> 12 months before the start of study

treatment) are eligible if they meet the following criteria:

• Did not discontinue because of tolerability concerns.
• Achieved either partial or CR to the bendamustine regimen of at least 12 months in duration before relapse/progression.
• Experienced progression following a regimen containing an alkylating agent.
• Received prior obinutuzumab.
• Received rituximab within 4 weeks of study start.
• Prior treatment-related toxicities that have not resolved to = Grade 1 before the date of study drug administration except for stable chronic toxicities (= Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
• Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Parsaclisib
Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
• Hexal
Bendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints.
• Gazyvaro
Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.

Locations

Country	Name	City	State
Czechia	FN Ostrava / Ostrava	Ostrava
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	The Finsen Centre, National Hospital	Copenhagen
Hungary	Semmelweis Egyetem	Budapest
Italy	Centro di Riferimento Oncologico	Aviano
Italy	Azienda Ospedaliero Universitaria Di Bologna	Bologna
Italy	Policlinico S. Orsola-Ematologia LA Seragnoli	Bologna
Italy	A.O. Spedali Civili	Brescia
Italy	UO Ematologia ASST Spedali Civili	Brescia
Spain	Hospital Germans Trias Pujol	Barcelona
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla
United States	Center for Cancer and Blood Disorders (CCBD) - Bethesda	Bethesda	Maryland
United States	University of Kansas Cancer Center	Fairway	Kansas
United States	Banner Health	Gilbert	Arizona
United States	University of California, San Diego	La Jolla	California
United States	Clinical Research Alliance	Lake Success	New York
United States	Froedtert & Medical College of Wisconsin & Affiliated Hospitals	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Czechia,  Denmark,  Hungary,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)		Screening through 30-35 days after end of treatment, up to approximately 34 months per subject
Secondary	Objective response rate based on Lugano classification criteria	Defined as percentage of subjects with a complete response (CR) and partial response (PR), as determined by investigator assessment of response	Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Secondary	Complete response rate based on Lugano classification criteria	Defined as percentage of subjects who achieve a best overall response of CR	Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Secondary	Duration of response	Defined as time from first documented evidence of CR or PR until earliest date of disease progression or death due to any cause.	Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Secondary	Progression-free survival	Defined as time from the date of the first dose of study drug until the earliest date of disease progression (determined by radiographic disease assessment/Lugano classification criteria) or death due to any cause.	Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Secondary	Overall survival	Defined as the time from the date of the first dose of study drug until death due to any cause.	From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject