Chronic lymphocytic leukemia MedDRA version: 16.1 Level: LLT Classification code 10068919 Term: B-cell chronic lymphocytic leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: Idelalisib
Product Code: GS-1101
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IDELALISIB
CAS Number: 870281-82-6
Current Sponsor code: GS-1101
Concentration unit: mg mill
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion 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. 2) CLL that warrants treatment (consistent with accepted IWCLL criteria for initiation of therapy). 3) Prior treatment for CLL comprising any of the following: a) Prior treatment with =1 regimen containing a therapeutic anti-CD20 antibody or b) Prior treatment with =2 regimens containing =1 cytotoxic agent 4) CLL progression 6 6) A negative serum pregnancy test for female subjects of child bearing 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 IMP is administered. 9) Evidence of a personally signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to the IMP, the metabolites, or formulation excipient. 2) Known histological transformation from CLL to an aggressive lymphoma (i.e., 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, non-alcoholic 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide idelalisib in an open-label format prior to the expected time of regulatory approval to subjects with relapsed CLL who have limited treatment options.;Secondary Objective: Not applicable;Primary end point(s): 1. Safety will be assessed with endpoints including incidence of SAEs = grade 3 and deaths. 2. Efficacy will be assessed using PFS, which is defined as the interval from the initial study dosing date to the first documentation of disease progression or death from any cause.;Timepoint(s) of evaluation of this end point: All the analyses will be limited to descriptive summaries. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Germany, Ireland, Italy, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed