Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02258529
Recruitment Status : Terminated
First Posted : October 7, 2014
Results First Posted : May 18, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Follicular Lymphoma
Small Lymphocytic Lymphoma
Interventions Drug: Idelalisib
Biological: Rituximab
Enrollment 10
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 14 September 2015. The last study visit occurred on 03 May 2016.
Pre-assignment Details 20 participants were screened.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description Idelalisib (Zydelig®) 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Period Title: Overall Study
Started 10
Completed 0
Not Completed 10
Reason Not Completed
Study Terminated by Sponsor             9
Adverse Event             1
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
69  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Hide Description [Not Specified]
Time Frame Up to 24 weeks plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: all participants who received at least 1 dose of study drug.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 90.0
Any SAEs 30.0
Any AE Leading to Idelalisib Interruption 60.0
Any AE Leading to Idelalisib Dose Reduction 30.0
Any AE Leading to Premature Discontinuation of IDL 10.0
Any AE Leading to Death 0
3.Secondary Outcome
Title Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
Hide Description The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.
Time Frame Up to 24 weeks plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: all participants who received at least 1 dose of study drug.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
Any Grade 3 or 4 ALT Elevation 40.0
Any Grade 3 or 4 AST Elevation 10.0
4.Secondary Outcome
Title Idelalisib Trough and Peak Plasma Concentrations
Hide Description [Not Specified]
Time Frame Predose and 1.5 hour postdose at Weeks 2, 4, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Set: all participants in the ITT Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 2 predose Number Analyzed 8 participants
216.2  (161.73)
Week 2 1.5 hours postdose Number Analyzed 9 participants
2240.0  (880.03)
Week 4 predose Number Analyzed 6 participants
347.4  (365.57)
Week 4 1.5 hours postdose Number Analyzed 6 participants
2084.3  (1346.26)
Week 12 predose Number Analyzed 5 participants
290.5  (373.08)
Week 12 1.5 hours postdose Number Analyzed 4 participants
1313.1  (1474.87)
5.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Progression-Free Survival
Hide Description 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 or death from any cause.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the interval from enrollment to death from any cause.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Changes in Health-Related Quality of Life
Hide Description Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.
Time Frame [Not Specified]
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the early termination of the study, data were not available for all participants, and therefore this prespecified analysis was not conducted.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to the last dose date plus 30 days (maximum: 24.1 weeks)
Adverse Event Reporting Description ITT Analysis Set: all participants who received at least 1 dose of study drug.
 
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
All-Cause Mortality
Idelalisib + Rituximab
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib + Rituximab
Affected / at Risk (%)
Total   3/10 (30.00%) 
General disorders   
Oedema peripheral  1  1/10 (10.00%) 
Infections and infestations   
Sepsis  1  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain  1  1/10 (10.00%) 
Nervous system disorders   
Trigeminal neuralgia  1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  1/10 (10.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idelalisib + Rituximab
Affected / at Risk (%)
Total   9/10 (90.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  3/10 (30.00%) 
Pancytopenia  1  1/10 (10.00%) 
Cardiac disorders   
Palpitations  1  1/10 (10.00%) 
Sinus tachycardia  1  1/10 (10.00%) 
Ear and labyrinth disorders   
Ear pruritus  1  1/10 (10.00%) 
Gastrointestinal disorders   
Abdominal distension  1  1/10 (10.00%) 
Abdominal pain  1  1/10 (10.00%) 
Constipation  1  1/10 (10.00%) 
Diarrhoea  1  3/10 (30.00%) 
Duodenal ulcer  1  1/10 (10.00%) 
Duodenitis  1  1/10 (10.00%) 
Gastritis  1  1/10 (10.00%) 
Hiatus hernia  1  1/10 (10.00%) 
Lip dry  1  1/10 (10.00%) 
Nausea  1  2/10 (20.00%) 
Oesophagitis  1  1/10 (10.00%) 
Stomatitis  1  1/10 (10.00%) 
Vomiting  1  3/10 (30.00%) 
General disorders   
Asthenia  1  1/10 (10.00%) 
Chills  1  2/10 (20.00%) 
Fatigue  1  3/10 (30.00%) 
Mucosal inflammation  1  1/10 (10.00%) 
Oedema peripheral  1  2/10 (20.00%) 
Peripheral swelling  1  1/10 (10.00%) 
Pyrexia  1  2/10 (20.00%) 
Hepatobiliary disorders   
Hepatic steatosis  1  1/10 (10.00%) 
Hepatitis acute  1  1/10 (10.00%) 
Periportal oedema  1  1/10 (10.00%) 
Immune system disorders   
Hypersensitivity  1  1/10 (10.00%) 
Infections and infestations   
Bronchitis  1  1/10 (10.00%) 
Oral candidiasis  1  1/10 (10.00%) 
Urinary tract infection  1  1/10 (10.00%) 
Injury, poisoning and procedural complications   
Fall  1  1/10 (10.00%) 
Infusion related reaction  1  4/10 (40.00%) 
Investigations   
Alanine aminotransferase increased  1  5/10 (50.00%) 
Aspartate aminotransferase increased  1  5/10 (50.00%) 
Blood cholesterol increased  1  1/10 (10.00%) 
Liver function test increased  1  2/10 (20.00%) 
Lymphocyte count decreased  1  1/10 (10.00%) 
Neutrophil count decreased  1  1/10 (10.00%) 
Platelet count decreased  1  1/10 (10.00%) 
Weight decreased  1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/10 (10.00%) 
Hypertriglyceridaemia  1  1/10 (10.00%) 
Hyperuricaemia  1  1/10 (10.00%) 
Hypophosphataemia  1  1/10 (10.00%) 
Lactic acidosis  1  1/10 (10.00%) 
Malnutrition  1  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/10 (10.00%) 
Muscular weakness  1  1/10 (10.00%) 
Musculoskeletal chest pain  1  1/10 (10.00%) 
Pain in extremity  1  2/10 (20.00%) 
Nervous system disorders   
Dementia  1  1/10 (10.00%) 
Dizziness  1  1/10 (10.00%) 
Dysarthria  1  1/10 (10.00%) 
Headache  1  1/10 (10.00%) 
Hypoaesthesia  1  1/10 (10.00%) 
Neuropathy peripheral  1  1/10 (10.00%) 
Paraesthesia  1  1/10 (10.00%) 
Transient ischaemic attack  1  1/10 (10.00%) 
Psychiatric disorders   
Acute psychosis  1  1/10 (10.00%) 
Delirium  1  1/10 (10.00%) 
Insomnia  1  1/10 (10.00%) 
Renal and urinary disorders   
Acute kidney injury  1  3/10 (30.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/10 (10.00%) 
Dysphonia  1  1/10 (10.00%) 
Dyspnoea  1  2/10 (20.00%) 
Dyspnoea exertional  1  1/10 (10.00%) 
Hypoxia  1  1/10 (10.00%) 
Oropharyngeal pain  1  1/10 (10.00%) 
Pneumonitis  1  1/10 (10.00%) 
Throat irritation  1  1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Dermatitis allergic  1  1/10 (10.00%) 
Ecchymosis  1  1/10 (10.00%) 
Hyperhidrosis  1  1/10 (10.00%) 
Night sweats  1  1/10 (10.00%) 
Rash  1  3/10 (30.00%) 
Rash maculo-papular  1  3/10 (30.00%) 
Urticaria  1  1/10 (10.00%) 
Vascular disorders   
Flushing  1  2/10 (20.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02258529     History of Changes
Other Study ID Numbers: GS-US-313-1414
First Submitted: October 3, 2014
First Posted: October 7, 2014
Results First Submitted: April 11, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 14, 2019