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)

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 23 November 2020
cancer
rituximab
measurable disease
bendamustine
obinutuzumab
refractory follicular lymphoma

Summary

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)

 

Description

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

 

For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Details
Condition Follicular Lymphoma
Clinical Study IdentifierTX151684
SponsorIncyte Corporation
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have Follicular Lymphoma?
Aged 18 or older
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 (CT) or magnetic resonance imaging (MRI)
Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy
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 phosphatidylinositol 3-kinase (PI3K) d inhibitor or a pan-PI3K inhibitor
Prior treatment with bendamustine (within 12 months of the start of study treatment)
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 date 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)
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