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Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

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ClinicalTrials.gov Identifier: NCT02044822
Recruitment Status : Terminated
First Posted : January 24, 2014
Results First Posted : May 11, 2017
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 B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
Interventions Drug: Idelalisib
Drug: Rituximab
Enrollment 102
Recruitment Details Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 06 August 2014. The last study visit occurred on 17 May 2016.
Pre-assignment Details 130 participants were screened.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Period Title: Overall Study
Started 102
Completed 9 [1]
Not Completed 93
Reason Not Completed
Study Terminated by Sponsor             77
Investigator's Discretion             10
Withdrew Consent             3
Initiation of Anti-Neoplastic Therapy             2
Lost to Follow-up             1
[1]
Completed = reached primary efficacy endpoint of progressive disease or death.
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Analysis Set: participants who received at least 1 dose of study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
66  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
44
  43.1%
Male
58
  56.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Asian
2
   2.0%
Black or African American
2
   2.0%
White
94
  92.2%
Not Permitted
4
   3.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Hispanic or Latino
6
   5.9%
Not Hispanic or Latino
91
  89.2%
Not Permitted
5
   4.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants
Romania 4
Hungary 2
United States 19
United Kingdom 11
Portugal 2
Spain 7
Austria 3
Czech Republic 9
Belgium 2
Denmark 1
Poland 15
Italy 14
Australia 6
France 7
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. 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 + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
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 + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Nodal Response Rate
Hide Description Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an 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 + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Complete Response Rate
Hide Description Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an 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 + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an 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 + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the interval from the start of study treatment 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 + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Minimal Residual Disease Negativity Rate at Week 36
Hide Description Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.
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 + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 17 months plus 30 days
Adverse Event Reporting Description Intent-to-Treat Analysis Set
 
Arm/Group Title Idelalisib + Rituximab
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
All-Cause Mortality
Idelalisib + Rituximab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib + Rituximab
Affected / at Risk (%)
Total   46/102 (45.10%) 
Blood and lymphatic system disorders   
Agranulocytosis  1  1/102 (0.98%) 
Febrile neutropenia  1  3/102 (2.94%) 
Thrombocytopenia  1  1/102 (0.98%) 
Cardiac disorders   
Atrial fibrillation  1  2/102 (1.96%) 
Cardiac failure  1  1/102 (0.98%) 
Coronary artery disease  1  1/102 (0.98%) 
Gastrointestinal disorders   
Colitis  1  6/102 (5.88%) 
Diarrhoea  1  6/102 (5.88%) 
Diarrhoea haemorrhagic  1  1/102 (0.98%) 
Enterocolitis  1  1/102 (0.98%) 
Gastrointestinal haemorrhage  1  1/102 (0.98%) 
Glossitis  1  1/102 (0.98%) 
Mouth ulceration  1  1/102 (0.98%) 
Oral mucosal eruption  1  1/102 (0.98%) 
Stomatitis  1  1/102 (0.98%) 
General disorders   
Malaise  1  1/102 (0.98%) 
Pyrexia  1  11/102 (10.78%) 
Infections and infestations   
Appendicitis  1  1/102 (0.98%) 
Clostridium difficile colitis  1  1/102 (0.98%) 
Conjunctivitis  1  1/102 (0.98%) 
Cytomegalovirus infection  1  1/102 (0.98%) 
Gastroenteritis  1  1/102 (0.98%) 
Herpes zoster  1  1/102 (0.98%) 
Influenza  1  1/102 (0.98%) 
Intestinal sepsis  1  1/102 (0.98%) 
Lower respiratory tract infection  1  2/102 (1.96%) 
Lower respiratory tract infection fungal  1  1/102 (0.98%) 
Oral candidiasis  1  1/102 (0.98%) 
Pneumocystis jirovecii infection  1  1/102 (0.98%) 
Pneumocystis jirovecii pneumonia  1  1/102 (0.98%) 
Pneumonia  1  5/102 (4.90%) 
Pneumonia bacterial  1  1/102 (0.98%) 
Pneumonia influenzal  1  1/102 (0.98%) 
Pneumonia pneumococcal  1  1/102 (0.98%) 
Pneumonia pseudomonal  1  1/102 (0.98%) 
Pseudomonal bacteraemia  1  1/102 (0.98%) 
Respiratory tract infection  1  1/102 (0.98%) 
Sepsis  1  1/102 (0.98%) 
Septic shock  1  2/102 (1.96%) 
Urinary tract infection  1  1/102 (0.98%) 
Injury, poisoning and procedural complications   
Infusion related reaction  1  1/102 (0.98%) 
Investigations   
Alanine aminotransferase increased  1  2/102 (1.96%) 
Aspartate aminotransferase increased  1  2/102 (1.96%) 
Body temperature increased  1  1/102 (0.98%) 
Liver function test increased  1  1/102 (0.98%) 
Transaminases increased  1  2/102 (1.96%) 
Metabolism and nutrition disorders   
Dehydration  1  1/102 (0.98%) 
Diabetic ketoacidosis  1  1/102 (0.98%) 
Dyslipidaemia  1  1/102 (0.98%) 
Hyperglycaemia  1  1/102 (0.98%) 
Metabolic acidosis  1  1/102 (0.98%) 
Tumour lysis syndrome  1  4/102 (3.92%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/102 (0.98%) 
Muscular weakness  1  1/102 (0.98%) 
Polymyalgia rheumatica  1  1/102 (0.98%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  1/102 (0.98%) 
Chronic lymphocytic leukaemia  1  1/102 (0.98%) 
Nervous system disorders   
Dysgeusia  1  1/102 (0.98%) 
Facial nerve disorder  1  1/102 (0.98%) 
Psychiatric disorders   
Confusional state  1  1/102 (0.98%) 
Renal and urinary disorders   
Acute kidney injury  1  2/102 (1.96%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/102 (0.98%) 
Cough  1  1/102 (0.98%) 
Epistaxis  1  1/102 (0.98%) 
Hiccups  1  1/102 (0.98%) 
Interstitial lung disease  1  1/102 (0.98%) 
Laryngeal pain  1  1/102 (0.98%) 
Pleuritic pain  1  1/102 (0.98%) 
Pneumonitis  1  2/102 (1.96%) 
Pulmonary embolism  1  1/102 (0.98%) 
Skin and subcutaneous tissue disorders   
Dermatitis exfoliative  1  1/102 (0.98%) 
Eczema  1  1/102 (0.98%) 
Psoriasis  1  1/102 (0.98%) 
Rash  1  2/102 (1.96%) 
Rash maculo-papular  1  2/102 (1.96%) 
Vascular disorders   
Hypotension  1  1/102 (0.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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   98/102 (96.08%) 
Blood and lymphatic system disorders   
Anaemia  1  14/102 (13.73%) 
Neutropenia  1  24/102 (23.53%) 
Thrombocytopenia  1  10/102 (9.80%) 
Gastrointestinal disorders   
Abdominal pain  1  8/102 (7.84%) 
Constipation  1  15/102 (14.71%) 
Diarrhoea  1  36/102 (35.29%) 
Dyspepsia  1  8/102 (7.84%) 
Mouth ulceration  1  6/102 (5.88%) 
Nausea  1  19/102 (18.63%) 
Vomiting  1  17/102 (16.67%) 
General disorders   
Asthenia  1  15/102 (14.71%) 
Chills  1  13/102 (12.75%) 
Fatigue  1  16/102 (15.69%) 
Oedema peripheral  1  11/102 (10.78%) 
Pyrexia  1  24/102 (23.53%) 
Infections and infestations   
Bronchitis  1  6/102 (5.88%) 
Nasopharyngitis  1  10/102 (9.80%) 
Oral candidiasis  1  6/102 (5.88%) 
Respiratory tract infection  1  6/102 (5.88%) 
Upper respiratory tract infection  1  7/102 (6.86%) 
Injury, poisoning and procedural complications   
Infusion related reaction  1  6/102 (5.88%) 
Investigations   
Alanine aminotransferase increased  1  39/102 (38.24%) 
Aspartate aminotransferase increased  1  22/102 (21.57%) 
Transaminases increased  1  6/102 (5.88%) 
Weight decreased  1  8/102 (7.84%) 
Metabolism and nutrition disorders   
Decreased appetite  1  9/102 (8.82%) 
Hypokalaemia  1  10/102 (9.80%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  8/102 (7.84%) 
Back pain  1  10/102 (9.80%) 
Myalgia  1  8/102 (7.84%) 
Pain in extremity  1  8/102 (7.84%) 
Nervous system disorders   
Dizziness  1  8/102 (7.84%) 
Headache  1  10/102 (9.80%) 
Psychiatric disorders   
Insomnia  1  7/102 (6.86%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  19/102 (18.63%) 
Dyspnoea  1  8/102 (7.84%) 
Epistaxis  1  6/102 (5.88%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  8/102 (7.84%) 
Rash  1  28/102 (27.45%) 
Rash maculo-papular  1  7/102 (6.86%) 
Vascular disorders   
Hypertension  1  7/102 (6.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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: NCT02044822     History of Changes
Other Study ID Numbers: GS-US-312-0133
2013-003314-41 ( EudraCT Number )
First Submitted: January 22, 2014
First Posted: January 24, 2014
Results First Submitted: March 30, 2017
Results First Posted: May 11, 2017
Last Update Posted: November 19, 2018