Non Hodgkin Lymphoma Clinical Trial

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

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).

View Eligibility Criteria

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) < 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

241

Study ID:

NCT01088048

Recruitment Status:

Completed

Sponsor:

Gilead Sciences

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There are 11 Locations for this study

See Locations Near You

Clearview Cancer Institute
Huntsville Alabama, 35805, United States
UCLA
Los Angeles California, 90024, United States
Stanford Cancer Center
Palo Alto California, 94304, United States
Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Weill Medical College of Cornell
New York New York, 10021, United States
Willamette Valley Cancer Institute and Research Center
Springfield Oregon, 97477, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer
Houston Texas, 77030, United States
North Star Lodge Cancer Center
Yakima Washington, 98902, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

241

Study ID:

NCT01088048

Recruitment Status:

Completed

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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