A study to optimize the dose of Idelalisib in Follicular Lymphoma

Phase 1

Conditions: Follicular Lymphoma
MedDRA version: 23.0Level: PTClassification code 10065856Term: Non-Hodgkin's lymphoma unspecified histology indolentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-000366-66-GB

Lead Sponsor: Gilead Sciences, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 266

Inclusion Criteria

1. Male or female = 18 years of age
2. Histologically confirmed diagnosis of B-cell FL, and grade limited to 1, 2 or 3a based on criteria established by the WHO 2008 classification of tumors of hematopoietic and lymphoid tissues
3. Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL and have no other therapeutic options
4. Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification
5. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures = 1.5 cm in the LD and = 1.0 cm in the LPD as assessed by PET CT, CT or MRI)
6. Has adequate performance status (such as ECOG Performance Status of = 2 or Karnofsky Performance Status of = 60)
7. Required baseline central laboratory data (within 4 weeks prior to start of study therapy) as shown in the table in the protocol.
8. For female subjects of childbearing potential, willingness to use a protocol recommended method of contraception during heterosexual intercourse from the signing of informed consent throughout the study treatment period and up to 30 days from the last dose of idelalisib (see Protocol)
9. For male subjects of reproductive potential having intercourse with females of childbearing potential, willing to use a protocol recommended method of contraception during heterosexual intercourse and to refrain from sperm donation throughout the study treatment period and for 90 days following discontinuation of idelalisib (see Protocol)
10. Lactating females must agree to discontinue nursing before study drug administration and at least 30 days following exposure
11. Indicate willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions
12. Evidence of a signed informed consent indicating that the subject is aware of the neoplastic nature of their disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation
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 123
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 123

Exclusion Criteria

1. History of lymphoid malignancy other than FL (eg, DLBCL)
2. Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
3. Known presence of intermediate- or high-grade myelodysplastic syndrome
4. Known history of serious allergic reaction including anaphylaxis or Stevens-Johnson syndrome/toxic epidermal necrolysis
5. History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for = 1 year prior to enrollment, or any other cancer or malignancy that has been in complete remission for = 5 years
6. Evidence of ongoing systemic infection (eg, bacterial, fungal, viral) at the time of enrollment
7. Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
8. History of or on-going drug-induced pneumonitis
9. History of or on-going inflammatory bowel disease
10. Known human immunodeficiency virus (HIV) infection
11. CMV: On-going infection, treatment, or prophylaxis within 28 days prior to the Screening Visit CMV test
12. Presence of any condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition
13. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
14. Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions or systemic corticosteroids for autoimmune anemia and/or thrombocytopenia
15. Concurrent participation in another therapeutic clinical trial
16. 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
17. Prior treatment with PI3K inhibitors

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

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