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

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ClinicalTrials.gov Identifier: NCT03039114
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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 : February 15, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021


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 Name: INCB050465

Drug: Hexal
Bendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints.
Other Name: Bendamustine

Drug: Gazyvaro
Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
Other Names:
  • Gazyva®
  • Obinutuzumab




Primary Outcome Measures :
  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) [ Time Frame: Screening through 30-35 days after end of treatment, up to approximately 34 months per subject ]

Secondary Outcome Measures :
  1. Objective response rate based on Lugano classification criteria [ Time Frame: 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

  2. Complete response rate based on Lugano classification criteria [ Time Frame: 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

  3. Duration of response [ Time Frame: 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.

  4. Progression-free survival [ Time Frame: 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.

  5. Overall survival [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039114


Locations
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United States, Arizona
Banner Health
Gilbert, Arizona, United States, 85234
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
United States, Kansas
University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
United States, Maryland
Center for Cancer and Blood Disorders (CCBD) - Bethesda
Bethesda, Maryland, United States, 20817
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
United States, Wisconsin
Froedtert & Medical College of Wisconsin & Affiliated Hospitals
Milwaukee, Wisconsin, United States, 53226
Czechia
FN Ostrava / Ostrava
Ostrava, Czechia, 70852
Denmark
Aarhus University Hospital
Aarhus, Denmark, DK-8000
Rigshospitalet
Copenhagen, Denmark, DK-2100
The Finsen Centre, National Hospital
Copenhagen, Denmark, DK-2100
Hungary
Semmelweis Egyetem
Budapest, Hungary, 1083
Italy
Centro di Riferimento Oncologico
Aviano, Italy, 33081
Azienda Ospedaliero Universitaria Di Bologna
Bologna, Italy, 40138
Policlinico S. Orsola-Ematologia LA Seragnoli
Bologna, Italy, 40138
A.O. Spedali Civili
Brescia, Italy, 25123
UO Ematologia ASST Spedali Civili
Brescia, Italy, 25123
Spain
Hospital Germans Trias Pujol
Barcelona, Spain, 08916
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28009
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Fitzroy Dawkins, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03039114     History of Changes
Other Study ID Numbers: INCB 50465-102 (CITADEL-102)
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Follicular lymphoma
relapsed
refractory
non-Hodgkin lymphoma
phosphatidylinositol 3-kinase (PI3K)
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine Hydrochloride
Obinutuzumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological