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
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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).
Official Title
A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
Eligibility 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
- - 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) < 1000/µL, unless it is related to underlying CLL, MCL or indolent NHL, the latter documented by > 50% infiltration of bone marrow by tumor cells - Has platelet count < 75000/µL, unless it is related to underlying CLL, MCL, or iNHL, the latter documented by > 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.
Investigator(s)
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Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
