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

NCT03039114 | Completed Phase 1 FDA Drug

• 3 other identifiers: INCB 50465-102 (CITADEL-102)Parsaclisib2016-002829-11
• Study Type: interventional
• Target: 26
• Locations: 6 countries
• Sites: 21

Brief 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).

Conditions

Lymphoma

Keywords

Follicular lymphoma; relapsed; refractory; non-Hodgkin lymphoma; phosphatidylinositol 3-kinase (PI3K)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective response rate based on Lugano classification criteria

  Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject

• Complete response rate based on Lugano classification criteria

  Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject

• Duration of response

  Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject

• Progression-free survival

  Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject

• Overall survival

  From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject

Study Arms (1)

Parsaclisib + Hexal and Gazyvaro

EXPERIMENTAL

Drug: Parsaclisib; Drug: Hexal; Drug: Gazyvaro

Interventions

Parsaclisib DRUG

Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.

Also known as: INCB050465

Parsaclisib + Hexal and Gazyvaro

Hexal DRUG

Bendamustine 90 mg/m\^2 administered intravenously at protocol-defined timepoints.

Also known as: Bendamustine

Parsaclisib + Hexal and Gazyvaro

Gazyvaro DRUG

Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.

Also known as: Gazyva®, Obinutuzumab

Parsaclisib + Hexal and Gazyvaro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 PI3Kδ 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).

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (21)

Banner Health

Gilbert, Arizona, 85234, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

Location

Center for Cancer and Blood Disorders (CCBD) - Bethesda

Bethesda, Maryland, 20817, United States

Location

Clinical Research Alliance

Lake Success, New York, 11042, United States

Location

Froedtert & Medical College of Wisconsin & Affiliated Hospitals

Milwaukee, Wisconsin, 53226, United States

Location

FN Ostrava / Ostrava

Ostrava, 70852, Czechia

Location

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

The Finsen Centre, National Hospital

Copenhagen, DK-2100, Denmark

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Centro di Riferimento Oncologico

Aviano, 33081, Italy

Location

Azienda Ospedaliero Universitaria Di Bologna

Bologna, 40138, Italy

Location

Policlinico S. Orsola-Ematologia LA Seragnoli

Bologna, 40138, Italy

Location

A.O. Spedali Civili

Brescia, 25123, Italy

Location

UO Ematologia ASST Spedali Civili

Brescia, 25123, Italy

Location

Hospital Germans Trias Pujol

Barcelona, 08916, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Recurrence; Lymphoma, Non-Hodgkin

Interventions

parsaclisib; Bendamustine Hydrochloride; obinutuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fitzroy Dawkins, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 1, 2017
• Study Start: February 15, 2017
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CZ (1); US (6); HU (1); ES (5); IT (5); DK (3)