Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin 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: NCT01393106
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : December 24, 2015
Last Update Posted : November 19, 2018
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
Condition Hodgkin Lymphoma
Intervention Drug: Idelalisib
Enrollment 25
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 15 September 2011. The last study visit occurred on 28 August 2014.
Pre-assignment Details 32 participants were screened.
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Period Title: Overall Study
Started 25
Completed 20 [1]
Not Completed 5
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             1
Lack of Efficacy             1
[1]
Completed: Disease Progression/Death
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
43  (16.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Asian 1
Black or African American 2
White 19
Other 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino 3
Not Hispanic or Latino 22
Time Since Diagnosis (years)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
3.9  (4.26)
Classical Hodgkin Lymphoma Pathologic Subtype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Nodular Sclerosis 23
Lymphocyte Rich 2
Disease Stage at Screening   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Stage I 1
Stage II 8
Stage III 6
Stage IV 10
[1]
Measure Description:

Disease stage was based on the Ann Arbor Lymphoma Staging System:

Stage I: Single lymph node group or lymph node region; Stage II: Two or more node regions on same side of diaphragm; Stage III: Lymph node regions on both sides of the diaphragm; Stage IV: Multiple extranodal sites or lymph nodes and extranodal sites

Karnofsky Performance Status   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants
83  (7.1)
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0-100; the lower the score, the worse the survival for most serious illnesses.
1.Primary Outcome
Title Overall Response Rate
Hide Description

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 proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator.

  • 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.
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.0
(6.8 to 40.7)
2.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
Responding Analysis Set: participants who achieved a best response of CR or PR.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: months
8.4 [1] 
(1.8 to NA)
[1]
Not reached
3.Secondary Outcome
Title Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically
Hide Description [Not Specified]
Time Frame Baseline, Week 8, Week 48, and up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 25
Median (Full Range)
Unit of Measure: percent change in SPD
Percent Change at Week 8 (n = 24)
-14.1
(-73.1 to 112.5)
Percent Change at Week 48 (n = 5)
-45.9
(-92.6 to 7.8)
Best Percent Change from Baseline (n = 24)
-24.1
(-92.6 to 112.5)
4.Secondary Outcome
Title Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)
Hide Description [Not Specified]
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Response
Hide Description Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
Responding Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 5
Median (Full Range)
Unit of Measure: months
2.0
(1.9 to 16.8)
6.Secondary Outcome
Title Overall Survival
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
19.8 [1] 
(12.3 to NA)
[1]
Not reached
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 Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
2.3
(1.8 to 3.7)
8.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
No data are presented because time to treatment failure data were not collected.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
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 as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire
Hide Description

Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline.

The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life.

Time Frame Baseline and up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.1  (7.24)
10.Secondary Outcome
Title Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age
Hide Description Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. 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 classifies patients 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.
Time Frame Baseline and up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Best Change 6  (5.3)
Worst Change -1  (6.9)
11.Secondary Outcome
Title Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines
Hide Description [Not Specified]
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not conducted due to discrepancies with the transfer of samples.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Overall Safety Profile of Idelalisib
Hide Description The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. "Clinically significant" abnormalities in ECG were as determined by the investigator.
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 96.0
Serious AE 36.0
Grade ≥ 3 AE 48.0
AE related to idelalisib 76.0
AE leading to permanent drug discontinuation 8.0
Clinically significant abnormal ECG at Week 16 0
Grade 3 or 4 hemoglobin 4.0
Grade 3 or 4 neutrophils 8.0
Grade 3 or 4 platelets 4.0
Grade 3 or 4 alanine aminotransferase 20.0
Grade 3 or 4 aspartate aminotransferase 16.0
13.Secondary Outcome
Title Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug
Hide Description [Not Specified]
Time Frame Up to Week 110
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: number of doses
Number of doses dispensed 463  (462.3)
Number of doses taken 329  (321.1)
14.Secondary Outcome
Title Idelalisib Trough and Peak Plasma Concentration at Week 4
Hide Description Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.
Time Frame Predose and 1.5 hours postdose at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: ng/mL
Trough – minimum (n = 20) 142
Trough – maximum (n = 20) 2120.0
Peak – minimum (n = 22) 90.2
Peak – maximum (n = 22) 8570.0
Time Frame Up to Week 110
Adverse Event Reporting Description ITT Analysis Set
 
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
All-Cause Mortality
Idelalisib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib
Affected / at Risk (%)
Total   9/25 (36.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/25 (4.00%) 
Gastrointestinal disorders   
Colitis  1  1/25 (4.00%) 
Vomiting  1  1/25 (4.00%) 
General disorders   
Pyrexia  1  1/25 (4.00%) 
Infections and infestations   
Herpes zoster  1  1/25 (4.00%) 
Lung infection  1  1/25 (4.00%) 
Pneumonia  1  1/25 (4.00%) 
Skin infection  1  1/25 (4.00%) 
Investigations   
Platelet count decreased  1  1/25 (4.00%) 
Metabolism and nutrition disorders   
Hypocalcaemia  1  1/25 (4.00%) 
Hypokalaemia  1  1/25 (4.00%) 
Hypomagnesaemia  1  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1  1/25 (4.00%) 
Pneumonitis  1  1/25 (4.00%) 
Productive cough  1  1/25 (4.00%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  2/25 (8.00%) 
Surgical and medical procedures   
Hospitalisation  1  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idelalisib
Affected / at Risk (%)
Total   24/25 (96.00%) 
Blood and lymphatic system disorders   
Anaemia  1  3/25 (12.00%) 
Leukopenia  1  4/25 (16.00%) 
Neutropenia  1  4/25 (16.00%) 
Thrombocytopenia  1  4/25 (16.00%) 
Cardiac disorders   
Tachycardia  1  2/25 (8.00%) 
Gastrointestinal disorders   
Abdominal pain  1  2/25 (8.00%) 
Abdominal pain upper  1  2/25 (8.00%) 
Constipation  1  6/25 (24.00%) 
Diarrhoea  1  3/25 (12.00%) 
Dyspepsia  1  4/25 (16.00%) 
Nausea  1  4/25 (16.00%) 
Vomiting  1  6/25 (24.00%) 
General disorders   
Chills  1  5/25 (20.00%) 
Fatigue  1  8/25 (32.00%) 
Pain  1  2/25 (8.00%) 
Pyrexia  1  6/25 (24.00%) 
Infections and infestations   
Upper respiratory tract infection  1  2/25 (8.00%) 
Injury, poisoning and procedural complications   
Fall  1  2/25 (8.00%) 
Investigations   
Alanine aminotransferase increased  1  5/25 (20.00%) 
Aspartate aminotransferase increased  1  6/25 (24.00%) 
Metabolism and nutrition disorders   
Hyperglycaemia  1  4/25 (16.00%) 
Hypoalbuminaemia  1  2/25 (8.00%) 
Hypocalcaemia  1  2/25 (8.00%) 
Hypokalaemia  1  2/25 (8.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  2/25 (8.00%) 
Muscle spasms  1  2/25 (8.00%) 
Musculoskeletal pain  1  2/25 (8.00%) 
Myalgia  1  2/25 (8.00%) 
Nervous system disorders   
Memory impairment  1  2/25 (8.00%) 
Neuropathy peripheral  1  3/25 (12.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/25 (20.00%) 
Dyspnoea  1  2/25 (8.00%) 
Skin and subcutaneous tissue disorders   
Night sweats  1  3/25 (12.00%) 
Rash  1  3/25 (12.00%) 
Vascular disorders   
Hypertension  1  2/25 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
There were no limitations affecting the analysis or results.
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: NCT01393106     History of Changes
Other Study ID Numbers: 101-11
First Submitted: July 11, 2011
First Posted: July 13, 2011
Results First Submitted: August 28, 2015
Results First Posted: December 24, 2015
Last Update Posted: November 19, 2018