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

Sponsor

Gilead Sciences (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT02136511

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia (CLL)	Drug: Idelalisib Drug: Rituximab

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego - Moores Cancer Center	La Jolla	California	United States	92093-0820
2	Georgetown University	Washington	District of Columbia	United States	20007
3	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
4	Weill Cornell Medical College	New York	New York	United States	10021
5	St. James University Hospital	Dublin		Ireland	8
6	Ospedale San Raffaele	Milano		Italy	20132
7	A.S.O. Molinette S. Giovanni Battista	Turin		Italy	10126
8	Hammersmith Hospital	London		United Kingdom	W12 0HS