18 and older, any sex, with Follicular Lymphoma or Small Lymphocytic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response RatePrimary· Start of Treatment to End of Treatment (up to 81 months)
Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC).
CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
PR was defined as a ≥ 50% reduction in the sum of the products of
Group
Value
95% CI
Idelalisib
57.6
48.4 – 66.4
Duration of ResponseSecondary· Start of Treatment to End of Treatment (up to 81 months)
Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.
Group
Value
95% CI
Idelalisib
12.5
6.2 – 28.6
Lymph Node Response RateSecondary· Start of Treatment to End of Treatment (up to 81 months)
Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.
Group
Value
95% CI
Idelalisib
56.8
47.6 – 65.6
Time to ResponseSecondary· Start of Treatment to End of Treatment (up to 81 months)
Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.
Group
Value
95% CI
Idelalisib
2.0
1.8 – 4.2
Progression-Free SurvivalSecondary· Start of Treatment to End of Treatment (up to 81 months)
Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. PFS was analyzed using KM estimates.
Group
Value
95% CI
Idelalisib
11.1
8.3 – 14.0
Overall SurvivalSecondary· Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause. OS was analyzed using KM estimates.
Group
Value
95% CI
Idelalisib
48.6
33.9 – 71.7
Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)Secondary· Baseline to End of Treatment (up to 81 months)
Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline.
The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications.
Group
Value
95% CI
Idelalisib
10.3
± 17.08
Change in Karnofsky Performance StatusSecondary· Baseline to End of Treatment (up to 81 months)
The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classified participants according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.
Best change
Group
Value
95% CI
Idelalisib
3.0
± 8.71
Worst change
Group
Value
95% CI
Idelalisib
-10.7
± 12.61
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or ElectrocardiogramsSecondary· Start of Treatment to End of Treatment (up to 81 months) plus 30 days
This composite endpoint measured the safety and tolerability profile of idelalisib. "Clinically meaningful" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.
Any AE
Group
Value
95% CI
Idelalisib
123
AE leading to drug discontinuation
Group
Value
95% CI
Idelalisib
35
Serious AE
Group
Value
95% CI
Idelalisib
72
Vital signs abnormal - clinically meaningful
Group
Value
95% CI
Idelalisib
0
ECG abnormal - clinically meaningful
Group
Value
95% CI
Idelalisib
0
Grade 3 or 4 hemoglobin
Group
Value
95% CI
Idelalisib
2
Grade 3 or 4 neutrophils
Group
Value
95% CI
Idelalisib
35
Grade 3 or 4 platelets
Group
Value
95% CI
Idelalisib
9
Study Drug ExposureSecondary· Start of Treatment to End of Treatment (up to 81 months)
The average idelalisib exposure was summarized.
Group
Value
95% CI
Idelalisib
13.2
± 15.08
Idelalisib Plasma ConcentrationSecondary· Predose and at 1.5 hours (± 5 minutes) postdose on Day 29
Predose
Group
Value
95% CI
Idelalisib
471.6
± 486.53
Postdose
Group
Value
95% CI
Idelalisib
2187.7
± 1050.76
PK Parameter: CmaxSecondary· Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.
Cmax at Day 1
Group
Value
95% CI
Idelalisib
2647.5
± 1084.99
Cmax at Day 29
Group
Value
95% CI
Idelalisib
2258.8
± 809.61
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06846671 — A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lympho
· Phase 3
· recruiting
NCT06205290 — A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Partici
· Phase 3
· withdrawn
NCT05725200 — Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
· Phase 2
· recruiting
NCT04699461 — Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or R
· Phase 2
· terminated
NCT03878524 — Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
· Phase 1
· terminated
NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
· Phase 2
· recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch
· Phase 3
· recruiting
NCT07126678 — Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma
· NA
· recruiting
NCT06860880 — Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
· NA
· recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 11 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01282424.