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

Sponsor

Incyte Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03039114

Collaborator

(none)

Enrollment

Locations

Arm

49.4

Actual Duration (Months)

1.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Parsaclisib Drug: Hexal Drug: Gazyvaro	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Feb 15, 2017

Actual Primary Completion Date :

Mar 30, 2021

Actual Study Completion Date :

Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parsaclisib + Hexal and Gazyvaro	Drug: Parsaclisib Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly. Other Names: INCB050465 Drug: Hexal Bendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints. Other Names: Bendamustine Drug: Gazyvaro Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints. Other Names: Gazyva® Obinutuzumab

Arm

Intervention/Treatment

Experimental: Parsaclisib + Hexal and Gazyvaro

Drug: Parsaclisib

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

Other Names:

INCB050465

Drug: Hexal

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

Other Names:

Bendamustine

Drug: Gazyvaro

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

Other Names:

Gazyva®

Obinutuzumab

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Objective response rate based on Lugano classification criteria [Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject]
Defined as percentage of subjects with a complete response (CR) and partial response (PR), as determined by investigator assessment of response
Complete response rate based on Lugano classification criteria [Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject]
Defined as percentage of subjects who achieve a best overall response of CR
Duration of response [Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject]
Defined as time from first documented evidence of CR or PR until earliest date of disease progression or death due to any cause.
Progression-free survival [Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject]
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.
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]
Defined as the time from the date of the first dose of study drug until death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Health	Gilbert	Arizona	United States	85234
2	University of California, San Diego	La Jolla	California	United States	92093
3	University of Kansas Cancer Center	Fairway	Kansas	United States	66205
4	Center for Cancer and Blood Disorders (CCBD) - Bethesda	Bethesda	Maryland	United States	20817
5	Clinical Research Alliance	Lake Success	New York	United States	11042
6	Froedtert & Medical College of Wisconsin & Affiliated Hospitals	Milwaukee	Wisconsin	United States	53226
7	FN Ostrava / Ostrava	Ostrava		Czechia	70852
8	Aarhus University Hospital	Aarhus		Denmark	DK-8000
9	Rigshospitalet	Copenhagen		Denmark	DK-2100
10	The Finsen Centre, National Hospital	Copenhagen		Denmark	DK-2100
11	Semmelweis Egyetem	Budapest		Hungary	1083
12	Centro di Riferimento Oncologico	Aviano		Italy	33081
13	Azienda Ospedaliero Universitaria Di Bologna	Bologna		Italy	40138
14	Policlinico S. Orsola-Ematologia LA Seragnoli	Bologna		Italy	40138
15	A.O. Spedali Civili	Brescia		Italy	25123
16	UO Ematologia ASST Spedali Civili	Brescia		Italy	25123
17	Hospital Germans Trias Pujol	Barcelona		Spain	08916
18	Hospital Universitario Gregorio Marañón	Madrid		Spain	28009
19	Hospital Universitario Fundación Jiménez Díaz	Madrid		Spain	28040
20	Hospital Universitario La Paz	Madrid		Spain	28046
21	Hospital Universitario Virgen del Rocío	Sevilla		Spain	41013