Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
