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

• Status: Completed
• Trial end date: 2015-04-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Antibodies, Monoclonal; Antineoplastic Agents; Bendamustine Hydrochloride; Bortezomib; Chlorambucil; Everolimus; Fludarabine; Fludarabine phosphate; Idelalisib; Immunologic Factors; Lenalidomide; Ofatumumab; Rituximab; Sirolimus; Thalidomide; Vidarabine

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) < 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.