Brief Title
Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
Official Title
A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents
Brief Summary
The primary objective will be to assess the overall response rate and to evaluate the
efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated
indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to
alkylating-agent-containing chemotherapy.
Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg
taken twice per day. Treatment with idelalisib can continue in compliant participants as long
as the study is still ongoing and the participants appear to be benefiting from treatment
with acceptable safety.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Response Rate
Secondary Outcome
Duration of Response
Condition
Follicular Lymphoma
Intervention
Idelalisib
Study Arms / Comparison Groups
Idelalisib
Description: Treatment with idelalisib will be continued until tumor progression or development of unacceptable toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
125
Start Date
March 18, 2011
Completion Date
May 16, 2018
Primary Completion Date
May 2, 2018
Eligibility Criteria
Key Inclusion Criteria:
- Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group [ECOG]
performance score of 0, 1, or 2)
- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
to the following:
- Follicular lymphoma (FL)
- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at
the time of diagnosis and on baseline laboratory assessment performed within 4
weeks prior to the start of study drug administration
- Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms
Macroglobulinemia (WM)
- Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
- Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for
iNHL
- Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
malignancy
- Prior treatment with rituximab and with an alkylating agent (eg, bendamustine,
cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for
iNHL
- Lymphoma that is refractory to rituximab and to an alkylating agent
- Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2
- For men and women of childbearing potential, willingness to abstain from sexual
intercourse or employ an effective method of contraception during the study drug
administration and follow-up periods
- Willingness and ability to provide written informed consent and to comply with the
protocol requirements
Key Exclusion Criteria:
- Central nervous system or leptomeningeal lymphoma
- Known histological transformation from iNHL to diffuse large B-cell lymphoma
- History of a non-lymphoma malignancy except for the following: adequately treated
local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
superficial bladder cancer, localized prostate cancer, other adequately treated Stage
1 or 2 cancer currently in complete remission, or any other cancer that has been in
complete remission for ≥ 5 years
- Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral
upper respiratory tract infections) at the time of initiation of study treatment
- Pregnancy or breastfeeding
- Ongoing alcohol or drug addiction
- Known history of drug-induced liver injury, chronic active hepatitis B infection,
chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic
steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by
stones, cirrhosis of the liver, or portal hypertension
- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may
be using topical or inhaled corticosteroids.
- Prior therapy with idelalisib
- Exposure to another investigational drug within 3 weeks prior to start of study
treatment
- Concurrent participation in another therapeutic treatment trial
- Prior or ongoing clinically significant illness, medical condition, surgical history,
physical finding, ECG finding, or laboratory abnormality that, in the investigator's
opinion, could affect the safety of the participant, alter the absorption,
distribution, metabolism or excretion of the study drug, or impair the assessment of
study results
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gilead Study Director, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01282424
Organization ID
101-09
Secondary IDs
2010-022155-33
Responsible Party
Sponsor
Study Sponsor
Gilead Sciences
Study Sponsor
Gilead Study Director, Study Director, Gilead Sciences
Verification Date
June 2019