Clinical Trials /

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

NCT03039114

Description:

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).

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

  • ORG STUDY ID: INCB 50465-102 (CITADEL-102)
  • NCT ID: NCT03039114

Conditions

  • Relapsed or Refractory Follicular Lymphoma

Interventions

DrugSynonymsArms
INCB050465INCB050465 + Hexal and Gazyvaro
HexalBendamustineINCB050465 + Hexal and Gazyvaro
GazyvaroGazyva®, ObinutuzumabINCB050465 + Hexal and Gazyvaro

Purpose

The purpose of this study is to evaluate the safety and efficacy of INCB050465 when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).

Trial Arms

NameTypeDescriptionInterventions
INCB050465 + Hexal and GazyvaroExperimental
  • INCB050465
  • Hexal
  • Gazyvaro

Eligibility 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of INCB050465 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 32 months per subject
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate based on Lugano classification criteria
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 31 months per subject
Safety Issue:
Description:Defined as percentage of subjects with a complete response (CR) and partial response (PR), as determined by investigator assessment of response
Measure:Complete response rate based on Lugano classification criteria
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 31 months per subject
Safety Issue:
Description:Defined as percentage of subjects who achieve a best overall response of CR
Measure:Duration of response
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 31 months per subject
Safety Issue:
Description:Defined as time from first documented evidence of CR or PR until earliest date of disease progression or death due to any cause.
Measure:Progression-free survival
Time Frame:Protocol-defined timepoints throughout the treatment period, up to approximately 31 months per subject
Safety Issue:
Description: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.
Measure:Overall survival
Time Frame:From the date of the first dose of study drug until death due to any cause, assessed up to approximately 44 months per subject
Safety Issue:
Description:Defined as the time from the date of the first dose of study drug until death due to any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

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

Last Updated

May 11, 2017