incb050465 in combination with rituximab, bendamustine and rituximab, or ibrutinib in participants with previously treated b-cell lymphoma (citadel-112)

Conditions: B-cell Lymphoma

Summary: the purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory b-cell lymphoma.


Eligibility criteria:
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 (see appendix d). * 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.

Keywords: diffuse large b-cell lymphoma (dlbcl) follicular lymphoma (fl) marginal zone lymphoma (mzl) mantle cell lymphoma (mcl) phosphatidylinositol 3-kinase delta (pi3kδ) inhibitor