Dose Optimization Study of Idelalisib in Follicular Lymphoma

  • End date
    Nov 30, 2030
  • participants needed
  • sponsor
    Gilead Sciences
Updated on 25 January 2022
ct scan
follicular lymphoma
refractory follicular lymphoma
lymphoid malignancy


The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.

Condition Follicular Lymphoma
Treatment Idelalisib
Clinical Study IdentifierNCT02536300
SponsorGilead Sciences
Last Modified on25 January 2022


Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of B-cell follicular lymphoma (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
Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL and have no other available therapeutic options. Note: Rituximab maintenance is not routinely considered a separate line of therapy when it is given as part of the prior rituximab-containing regimen given over a number of cycles followed by maintenance. Rituximab monotherapy may be considered a separate line of therapy when disease relapse occurs between the initiation of rituximab monotherapy and the preceding line of therapy. If there are any ambiguities about eligibility, the site should consult with the medical monitor
Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of 1 lesion that measures 1.5 cm in the longest dimension (LD) and 1.0 cm in the longest perpendicular dimension (LPD) as assessed by positron emission tomography-computed tomography (PET-CT), computed tomography (CT) or magnetic resonance imaging (MRI)
Required baseline central laboratory data in protocol
For female individuals of childbearing potential and male individuals of reproductive potential, willingness to use a protocol- recommended method of contraception
Lactating females must agree to discontinue nursing
Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)

Exclusion Criteria

History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma)
Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
Known presence of intermediate- or high-grade myelodysplastic syndrome
Known history of serious allergic reaction including anaphylaxis or Stevens- Johnson syndrome/ toxic epidermal necrolysis
History of a non-lymphoid malignancy except for protocol allowed exceptions
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
Known history of drug-induced liver injury, chronic active hepatitis B virus (HBV), chronic active hepatitis C virus (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
History of or ongoing drug-induced pneumonitis
History of or ongoing inflammatory bowel disease
Known human immunodeficiency virus (HIV) infection
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
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 and systemic steroids for autoimmune anemia and/or thrombocytopenia
Concurrent participation in another therapeutic clinical trial
Prior treatment with phosphatidylinositol 3-kinase (PI3K) inhibitors
Cytomegalovirus (CMV): Ongoing infection, treatment, or specifically CMV antiviral prophylaxis within 28 days prior to the screening visits CMV test
Note: Other protocol defined Inclusion/ Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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