This trial is active, not recruiting.

Conditions indolent non-hodgkin lymphoma, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, marginal zone lymphoma
Treatment idelalisib
Phase phase 2
Target PI3K
Sponsor Gilead Sciences
Start date May 2011
End date June 2013
Trial size 120 participants
Trial identifier NCT01282424, 101-09, 2010-022155-33


The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to assess the overall response rate.

Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant patients as long as the study is still ongoing and the patients appear to be benefiting from treatment with acceptable safety.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
idelalisib GS-1101
Idelalisib 150 mg taken twice daily by mouth

Primary Outcomes

Overall Response Rate during treatment with idelalisib based on standard criteria
time frame: Every 8-12 weeks

Secondary Outcomes

Duration of Response
time frame: Every 8-12 weeks
Change from baseline in the sum of the product of the greatest perpendicular diameters of the target lymph nodes
time frame: Every 8-12 weeks
Time to Treatment Response
time frame: Every 8-12 weeks
Progression Free Survival
time frame: Every 8-12 weeks
Time to Treatment Failure
time frame: Every 8-12 weeks
Changes in health-related quality of life events
time frame: Every 4-12 weeks
Changes in performance status
time frame: Every 4-12 weeks
Changes in plasma concentrations of disease-associated chemokines and cytokines
time frame: Every 2-12 weeks
Overall safety profile of idelalisib
time frame: Every 2-12 weeks
Study Drug administration and compliance
time frame: Every 4-12 weeks
Idelalisib plasma exposure over time
time frame: Every 4-8 weeks for 16 weeks
Pharmacokinetic parameters for patients participating in sub-study
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age ≥ 18 years - Karnofsky performance score 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 - Lymphoplasmacytoid 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 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. Patients 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 patient, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results

Additional Information

Official title A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients With Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.
Location data was received from the National Cancer Institute and was last updated in April 2016.