A study to provide access to idelalisib in combination with rituximab for the treatment of previously treated chronic lymphocytic leukemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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 <24 months since the completion of the last prior therapy for CLL.
5) Appropriate for non-cytotoxic-containing therapy based on the presence of any of the following factors:
a) 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
b) Estimated creatinine clearance (eCCr) <60 mL/min (as determined by the Cockcroft-Gault method), or
c) A Cumulative Illness Rating Scale (CIRS) score of >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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide idelalisib in an open-label format prior to the expected time of regulatory approval to subjects with relapsed<br>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.<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA

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