Clinical trial NCT02136511: Expanded Access for Idelalisib in Combination With Rituximab in Chronic Lymphocytic Leukemia
Official title: An Expanded Access Protocol for Idelalisib in Combination With Rituximab for Relapsed, Previously Treated Subjects With Chronic Lymphocytic Leukemia
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Chronic Lymphocytic Leukemia (CLL)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-05-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility criteria: 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 administered.
9. Evidence of a personally signed informed consent

Exclusion Criteria:

1. Known hypersensitivity to the idelalisib, its metabolites, or formulation excipient(s)
2. Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
3. Known myelodysplastic syndrome
4. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
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 antibodies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego - Moores Cancer Center
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Dublin
country: Ireland
facility: St. James University Hospital
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Turin
country: Italy
facility: A.S.O. Molinette S. Giovanni Battista
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Gilead Sciences
name: Thomas Jahn, MD
role: STUDY_DIRECTOR
References: