Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences


  • Drug: Idelalisib
  • Drug: Rituximab
  • Drug: Bendamustine
  • Drug: Ofatumumab
  • Drug: Fludarabine
  • Drug: Everolimus
  • Drug: Bortezomib
  • Drug: Chlorambucil
  • Drug: Lenalidomide


Phase 1


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

   - 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

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting