A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab,or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

  • STATUS
    Recruiting
Updated on 10 May 2022
lymphomas
lymphoma
b-cell lymphoma

Summary

The purpose of this study is to evaluate the safety and tolerability of INCB050465 when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.

 

Description

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

Details
Condition Lymphoma, Lymphoma, B-Cell, Lymphoma, B-Cell
Clinical Study IdentifierTX218048
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women, aged 18 years or older on the day of signing the Informed Consent Form (ICF)
Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL
Participants with DLBCL, MZL or MCL must have received at least 1 prior line of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen
Participants with FL must have received at least 2 prior lines of systemic therapy with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen
Ineligible for stem cell transplant
Participants with DLBCL must have failed or refused stem cell transplantation or failed first-line salvage therapy if ineligible for transplantation
Must be willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue
Life expectancy of > 3 months
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
Adequate hematologic, hepatic, and renal function
Willingness to avoid pregnancy or fathering a child
Ability to comprehend and willingness to sign an ICF

Exclusion Criteria

Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL)
Histologically confirmed rare non-Hodgkin B-cell subtypes
History of or central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease
Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor
For participants to be treated with bendamustine (Treatment B), prior treatment with bendamustine (within 12 months of the start of study treatment). Participants 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 response (PR) or complete response (CR) to the bendamustine regimen of at least 12 months in duration before relapse/progression
Experienced progression following a regimen containing an alkylating agent
For participants to be treated with ibrutinib (Treatment C), prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment
Active graft-versus-host disease following allogeneic transplant
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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