Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia
An Expanded Access Protocol for Idelalisib in Combination With Rituximab for Relapsed, Previously Treated Subjects With Chronic Lymphocytic Leukemia
2 other identifiers
expanded_access
N/A
4 countries
8
Brief Summary
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.
Trial Health
Trial Health Score
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8 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedOctober 28, 2014
October 1, 2014
May 9, 2014
October 27, 2014
Conditions
Interventions
Idelalisib 150 mg tablet administered orally twice daily
Rituximab administered intravenously starting at 375 mg/m\^2 at Week 0 and continuing with a dose of 500 mg/m\^2 at Weeks 2, 4, 6, 8, 12, 16, and 20.
Eligibility Criteria
You may qualify if:
- 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
- CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation of therapy)
- Prior treatment for CLL comprising any of the following:
- Prior treatment with ≥ 1 regimen containing a therapeutic anti-CD20 antibody or
- Prior treatment with ≥ 2 regimens containing ≥ 1 cytotoxic agent
- CLL progression \< 24 months since the completion of the last prior therapy for CLL
- Appropriate for noncytotoxic-containing therapy based on the presence of any of the following factors:
- 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
- Estimated creatinine clearance \< 60 mL/min (as determined by the Cockcroft-Gault method), or
- A Cumulative Illness Rating Scale (CIRS) score of \> 6
- A negative serum pregnancy test for female subjects of childbearing potential
- Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
- Lactating females must agree to discontinue nursing before the study drug is administered.
- Evidence of a personally signed informed consent
You may not qualify if:
- Known hypersensitivity to the idelalisib, its metabolites, or formulation excipient(s)
- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
- Known myelodysplastic syndrome
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
- 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
- Ongoing drug-induced pneumonitis
- Ongoing inflammatory bowel disease
- History of anaphylaxis in association with previous administration of monoclonal antibodies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (8)
University of California, San Diego - Moores Cancer Center
La Jolla, California, 92093-0820, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Weill Cornell Medical College
New York, New York, 10021, United States
St. James University Hospital
Dublin, 8, Ireland
Ospedale San Raffaele
Milan, 20132, Italy
A.S.O. Molinette S. Giovanni Battista
Turin, 10126, Italy
Hammersmith Hospital
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Jahn, MD
Gilead Sciences