A Study of Idelalisib in Combination with Rituximab for Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1) Male or female =18 years of age.
2) Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008.
3) Presence of 17p deletion in CLL cells as demonstrated by FISH testing performed at a central laboratory.
4) No prior therapy for CLL other than corticosteroids for disease complications.
5) CLL that warrants treatment based on pre-defined criteria.
6) Presence of measurable lymphadenopathy confirmed by the Independent Review Committee (IRC) (defined as the presence of =1 nodal lesion that measures =2.0 cm in the longest dimension [LD] and =1.0 cm in the longest perpendicular dimension [LPD] as assessed by computed tomography [CT] or magnetic resonance imaging [MRI]).
7) ECOG performance status of =2.
8) Required baseline laboratory data (within 28 days prior to enrollment) as shown in the protocol.
9) For female subjects of childbearing potential, willing to use a protocol-recommended method of contraception from the signing of informed consent throughout the study treatment period and 30 days from the last dose of IDELA or 12 months from the last dose of rituximab, whichever is later.
10) Male subjects of reproductive potential having intercourse with females of childbearing potential, must agree to utilize protocol specified
methods of contraception and refrain from sperm donation from the enrollment visit throughout the study treatment period and up to 3
months from the last dose of IDELA or 12 months from the last dose of rituximab, whichever is later.
11) Lactating females must agree to discontinue nursing before study drug administration.
12) Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions.
13) Evidence of a 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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1) Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation).
2) Known presence of myelodysplastic syndrome.
3) History of a non-CLL malignancy with the following exceptions:
a) the malignancy has been in remission without treatment for =5 years prior to enrollment, or
b) carcinoma in situ of the cervix, or
c) adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
d) asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for =1 year prior to enrollment, or
e) DCIS of the breast treated with lumpectomy alone, or
f) Other adequately treated Stage 1 or 2 cancer currently in complete remission.
4) Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for IDELA, or rituximab.
5) Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment.
6) Ongoing drug-induced liver injury, alcoholic liver disease, non alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
7) History of non-infection pneumonitis.
8) Ongoing inflammatory bowel disease.
9) History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
10) Ongoing immunosuppressive therapy other than corticosteroids.
11) Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment.
12) Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results.
13) Subject has undergone major surgery other than diagnosis surgery within 30 days prior to enrollment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

A Study of Idelalisib in Combination with Rituximab for Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletio

Recruitment & Eligibility

Study & Design

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