study to investigate idelalisib in combination with chemotherapeutic agents, immunomodulatory agents and anti-cd20 monoclonal antibody (mab) in participants with relapsed or refractory indolent b-cell non-hodgkin's lymphoma, mantle cell lymphoma or chronic lymphocytic leukemia

Conditions: Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma

Summary: the primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-cd20 monoclonal antibody (mab), a chemotherapeutic agent, a mammalian target of rapamycin (mtor) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent b-cell non-hodgkin lymphoma (nhl), mantle cell lymphoma (mcl), or chronic lymphocytic leukemia (cll).


Eligibility criteria:
key inclusion criteria: * age ≥ 18 * previously treated with relapsed or refractory disease (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen) * disease status requirement: * for cll patients, symptomatic disease that mandates treatment as defined by the international workshop on chronic lymphocytic lymphoma (iwcll) 2008 criteria * for indolent nhl and mcl patients, measurable disease by ct scan defined as at least 1 lesion that measures \> 2 cm in a single dimension * who performance status of ≤ 2 * for men and women of child-bearing potential, willing to use adequate contraception (ie, latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study. * for cohort 7 only: women of child bearing potential must have 2 negative pregnancy tests prior to starting lenalidomide. * able to provide written informed consent key exclusion criteria: * is not a good candidate to receive any of the drugs administered in the study for a given disease (idelalisib, bendamustine, rituximab, ofatumumab, fludarabine, everolimus, bortezomib, or chlorambucil), according to the clinical judgment of the investigator * patients with atypical immunophenotype with t(11:14) translocation or cyclin d1 over-expression (cll patients only) * had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to the baseline disease status tests * had treatment with a short course of corticosteroids for symptom relief within 1-week prior to the baseline disease status tests * has had an allogeneic hematopoietic stem cell transplant * has known active central nervous system involvement of the malignancy * is pregnant or nursing * has active, serious infection requiring systemic therapy. patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the investigator * has absolute neutrophil count (anc) \ 50% infiltration of bone marrow by tumor cells * has platelet count \ 50% infiltration of bone marrow by tumor cells * has serum creatinine ≥ 2.0 mg/dl * for cohort 7 only: has creatinine clearance \< 60 ml/min * has serum bilirubin ≥ 2 mg/dl (unless due to gilbert's syndrome) for patients with inhl or cll; for patients with mcl, serum bilirubin ≥ 1.5 x upper limit of normal * has serum aspartate aminotransferase (ast)/alanine aminotransferase (alt) ≥ 2 x upper limit of normal * has child-pugh class b or c hepatic impairment * has a positive test for hiv antibodies * has active hepatitis b or c (confirmed by rna test). patients with serologic evidence of prior exposure are eligible. * prior treatment with idelalisib note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: phosphatidylinositol 3-kinase ofatumumab indolent non-hodgkin lymphoma (inhl)