Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia

Conditions:Blood Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Contact:Sissy Peterman

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An Expanded Access Protocol for Idelalisib in Combination With Rituximab for Relapsed, Previously Treated Subjects With Chronic Lymphocytic Leukemia

This study is to provide idelalisib (IDELA) to individuals with relapsed, previously treated
chronic lymphocytic leukemia (CLL) who have limited treatment options and are not eligible
for other Gilead-sponsored studies.

Inclusion Criteria:

1. Male or female ≥ 18 years of age with a diagnosis of B-cell CLL established according
to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria and
documented within medical records

2. CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation
of therapy)

3. Prior treatment for CLL comprising any of the following:

1. Prior treatment with ≥ 1 regimen containing a therapeutic anti-CD20 antibody or

2. Prior treatment with ≥ 2 regimens containing ≥ 1 cytotoxic agent

4. CLL progression < 24 months since the completion of the last prior therapy for CLL

5. Appropriate for noncytotoxic-containing therapy based on the presence of any of the
following factors:

1. Grade ≥ 3 neutropenia or thrombocytopenia attributable to cumulative
myelotoxicity from prior administration of cytotoxic agents (as documented by
bone marrow biopsy obtained since last prior therapy), or

2. Estimated creatinine clearance < 60 mL/min (as determined by the Cockcroft-Gault
method), or

3. A Cumulative Illness Rating Scale (CIRS) score of > 6

6. A negative serum pregnancy test for female subjects of childbearing potential

7. Male and female subjects of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception.

8. Lactating females must agree to discontinue nursing before the study drug is

9. Evidence of a personally signed informed consent

Exclusion Criteria:

1. Known hypersensitivity to the idelalisib, its metabolites, or formulation

2. Known histological transformation from CLL to an aggressive lymphoma (ie, Richter

3. Known myelodysplastic syndrome

4. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of

5. Ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active
hepatitis B (HBV), alcoholic liver disease, nonalcoholic steatohepatitis, primary
biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of
the liver, or portal hypertension

6. Ongoing drug-induced pneumonitis

7. Ongoing inflammatory bowel disease

8. History of anaphylaxis in association with previous administration of monoclonal
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Atlanta, Georgia 30322
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