Clareo Health | INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
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Keep this study
Lead
Incyte Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 (see Appendix D).
Willingness to avoid pregnancy or fathering a child.
Ability to comprehend and willingness to sign an ICF
* 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.
You may not be if
Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
