Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Lymphoma, Non-Hodgkin

Leukemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Leukemia, Lymphoid

Hematologic Diseases

Chronic Disease

Disease Attributes

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Chronic Lymphocytic Leukemia

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Chronic Graft Versus Host Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Idelalisib

Alkylating Agents

Enzyme Inhibitors

Treatment with idelalisib will be continued until tumor progression or development of unacceptable toxicity.

Idelalisib 150 mg tablet administered orally twice daily

Gilead Study Director

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.

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas

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

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

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 the longest perpendicular diameters of all index lesions, with no new lesions.

For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)

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.

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.

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.

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.

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.

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.

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.

Analysis of the cytokine/chemokine was planned to be performed on a subset of samples from this study along with a subset of samples from other studies. Therefore, data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

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.

The average idelalisib exposure was summarized.

Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.

Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).

AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration

Gilead Sciences

ITT Analysis Set included enrolled participants who received at least one dose of study drug.

Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.

Age, Continuous

Sex: Female, Male

Race

Race/Ethnicity, Customized

Ethnicity

France

United States

Poland

Germany

United Kingdom

Italy

Region of Enrollment

Karnofsky performance status classified participants according to their functional impairment. Scores ranged from 0-100, the lower the score, the worse the survival for most serious illnesses.

Karnofsky Performance Status

LPL/WM: Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia

Baseline Disease History

ITT analysis set included enrolled participants who received at least one dose of study drug.

Gilead Clinical Study Information Center

Overall Response Rate

Participants in the ITT Analysis Set who achieved a CR or PR (or MR for participants with WM) were analyzed.

Duration of Response

Participants in the ITT Analysis Set were analyzed.

Lymph Node Response Rate

Time to Response

Progression-Free Survival

Overall Survival

Participants in the ITT Analysis Set with available data were analyzed.

Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)

Best change

Worst change

Change in Karnofsky Performance Status

Changes in Plasma Concentrations of Disease-Associated Chemokines and Cytokines

Any AE

AE leading to drug discontinuation

Serious AE

Vital signs abnormal - clinically meaningful

ECG abnormal - clinically meaningful

Grade 3 or 4 hemoglobin

Grade 3 or 4 neutrophils

Grade 3 or 4 platelets

Grade 3 or 4 alanine aminotransferase

Grade 3 or 4 aspartate aminotransferase

Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms

Study Drug Exposure

Predose

Postdose

Pharmacokinetic (PK) Analysis Set included participants in the ITT Analysis Set who had the necessary baseline and on-study measurements.

Spots Global Cancer Trial Database for lymphoplasmacytoid lymphoma (lpl)