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This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL.
This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib | Experimental | This arm consists of 2 cohorts. Participants in Cohort 1 will receive idelalisib for up to twelve 28-day cycles (or development of unacceptable toxicity) plus rituximab (8 doses through the end of Cycle 2). Upon completion of twelve 28-cycles, participants are eligible to remain on idelalisib in a continuation protocol. Participants in Cohort 2 will receive idelalisib until disease progression or development of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Idelalisib 150 mg tablets administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was assessed based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria as specifically modified for this study to reflect current recommendations which consider the mechanism of action of idelalisib and similar drugs, and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. Based on the CLL response definition in the protocol (modified Hallek 2008), the parameters of lymphadenopathy, liver and/or spleen size, constitutional symptoms, polymorphonuclear leukocytes, circulating clonal B-lymphocytes, platelet count, hemoglobin, and marrow were assessed.
| Up to 28 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Safety of Idelalisib | The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib). | Up to 28 Months |
| Lymphadenopathy Response Rate |
Not provided
Key Inclusion Criteria:
Histologically or cytologically confirmed CLL or SLL.
Age ≥ 65
Presence of measurable lymphadenopathy (defined as the presence of ≥1 nodal lesion that measures ≥ 1.5 cm in the longest diameter (LD) and ≥ 1.0 cm in the longest perpendicular diameter (LPD) as assessed by physical exam, computed tomography (CT) or magnetic resonance imaging (MRI)).
CLL - Binet Stage C or Rai Stage III or IV or has active disease defined by meeting at least one of the following criteria:
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
Massive (ie, > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
Massive nodes (ie, > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time of less than 6 months
Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy
At least one of the following disease-related symptoms:
SLL - has active disease as defined above for CLL, except the lymphocytosis criterion does not apply
World Health Organization (WHO) Performance Status of ≤ 2
For men of child-bearing potential, willing to use adequate methods of contraception for the entire duration of the study
Able to provide written informed consent
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego, Moores Cancer Center | La Jolla | California | 92093-0820 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26472751 | Derived | O'Brien SM, Lamanna N, Kipps TJ, Flinn I, Zelenetz AD, Burger JA, Keating M, Mitra S, Holes L, Yu AS, Johnson DM, Miller LL, Kim Y, Dansey RD, Dubowy RL, Coutre SE. A phase 2 study of idelalisib plus rituximab in treatment-naive older patients with chronic lymphocytic leukemia. Blood. 2015 Dec 17;126(25):2686-94. doi: 10.1182/blood-2015-03-630947. Epub 2015 Oct 15. |
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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.
18 months after study completion
A secured external environment with username, password, and RSA code.
113 participants were screened.
Participants were enrolled at study sites in the United States. The first participant was screened on 28 September 2010. The last study visit occurred on 07 June 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idelalisib+Rituximab (Cohort 1) | Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses |
| FG001 | Idelalisib (Cohort 2) | Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) Analysis Set: participants who received at least 1 dose of idelalisib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Idelalisib+Rituximab (Cohort 1) | Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | ORR was assessed based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria as specifically modified for this study to reflect current recommendations which consider the mechanism of action of idelalisib and similar drugs, and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. Based on the CLL response definition in the protocol (modified Hallek 2008), the parameters of lymphadenopathy, liver and/or spleen size, constitutional symptoms, polymorphonuclear leukocytes, circulating clonal B-lymphocytes, platelet count, hemoglobin, and marrow were assessed.
| Intent-to-treat (ITT) Analysis Set: participants who received at least 1 dose of idelalisib. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 28 Months |
Up to 28 Months
Adverse events were coded according to MedDRA Version 15.1 for Cohort 1 and MedDRA Version 19.0 for Cohort 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Idelalisib+Rituximab (Cohort 1) | Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
Not provided
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C552946 | idelalisib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rituximab | Drug | Rituximab 375 mg/m^2 administered intravenously once weekly x 8 weeks |
|
|
Lymphadenopathy response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in the sum of the perpendicular diameters of all measurable lesions while receiving study therapy. |
| Baseline and up to 28 Months |
| Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of All Measurable Lesions | Baseline; Weeks 8, 16, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
| Duration of Response | Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause. | Up to 28 Months |
| Progression-Free Survival | Progression-free survival (PFS) was defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause. Progression was defined using the Standardized IWCLL criteria as specifically modified for this study to consider the mechanism of action of idelalisib and similar drugs. The occurrence of any of the following events indicated progression:
| Up to 28 Months |
| Idelalisib Plasma Concentrations (Cohort 1) | Predose and 1.5 hours postdose at Weeks 0, 4, and 24 |
| Idelalisib Plasma Concentrations (Cohort 2) | Predose and 1.5 hours postdose at Weeks 0 and 4 and predose at Weeks 8 and 20 |
| Changes in Potential Pharmacodynamic Markers of Drug Activity in Plasma and Whole Blood | Changes in potential pharmacodynamic markers of drug activity will include assessments of chemokine and cytokine concentrations, effects on the activity of PI3K and related pathways, and effect on cell migration and other functional outcomes. This endpoint will be assessed at the following time points:
| Up to 169 days |
| Overall Survival | Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause. | Up to 28 Months |
| Stanford University School of Medicine |
| Stanford |
| California |
| 94304 |
| United States |
| Columbia University - Herbert Irving Pavilion | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| The Universtity of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Withdrew Consent |
|
| Investigator Request |
|
| Study Terminated by Sponsor |
|
| Poor tolerance of study drug |
|
| Adverse Event |
|
| Idelalisib (Cohort 2) |
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Idelalisib+Rituximab (Cohort 1) | Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses |
| OG001 | Idelalisib (Cohort 2) | Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity |
|
|
| Secondary | Overall Safety of Idelalisib | The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib). | ITT Analysis Set | Posted | Number | percentage of participants | Up to 28 Months |
|
|
|
| Secondary | Lymphadenopathy Response Rate | Lymphadenopathy response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in the sum of the perpendicular diameters of all measurable lesions while receiving study therapy. | Participants in the ITT Analysis Set with baseline measurable lymph nodes were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and up to 28 Months |
|
|
|
| Secondary | Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of All Measurable Lesions | Participants in the ITT Analysis Set with available data were analyzed. | Posted | Median | Full Range | percent change | Baseline; Weeks 8, 16, 24, 36, 48, 60, 72, 84, 96, 108, and 120 |
|
|
|
| Secondary | Duration of Response | Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause. | Participants in the ITT Analysis Set who achieved complete or partial response. | Posted | Median | 95% Confidence Interval | months | Up to 28 Months |
|
|
|
| Secondary | Progression-Free Survival | Progression-free survival (PFS) was defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause. Progression was defined using the Standardized IWCLL criteria as specifically modified for this study to consider the mechanism of action of idelalisib and similar drugs. The occurrence of any of the following events indicated progression:
| ITT Analysis Set | Posted | Median | 95% Confidence Interval | months | Up to 28 Months |
|
|
|
| Secondary | Idelalisib Plasma Concentrations (Cohort 1) | Pharmacokinetic (PK) Analysis Set: participants in the ITT Analysis Set from Cohort 1 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest. | Posted | Median | Inter-Quartile Range | ng/mL | Predose and 1.5 hours postdose at Weeks 0, 4, and 24 |
|
|
|
| Secondary | Idelalisib Plasma Concentrations (Cohort 2) | PK Analysis Set: participants in the ITT Analysis Set from Cohort 2 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest. | Posted | Median | Inter-Quartile Range | ng/mL | Predose and 1.5 hours postdose at Weeks 0 and 4 and predose at Weeks 8 and 20 |
|
|
|
| Secondary | Changes in Potential Pharmacodynamic Markers of Drug Activity in Plasma and Whole Blood | Changes in potential pharmacodynamic markers of drug activity will include assessments of chemokine and cytokine concentrations, effects on the activity of PI3K and related pathways, and effect on cell migration and other functional outcomes. This endpoint will be assessed at the following time points:
| The collection of plasma samples for pharmacodynamic (PD) analysis in this study was planned prior to the availability of results from an identical PD analysis in another idelalisib study with a larger sample size (n = 176 unique subjects with 2085 longitudinal plasma samples). Therefore, PD analysis was not performed in this study (n = 41). | Posted | Up to 169 days |
|
|
| Secondary | Overall Survival | Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause. | Overall survival analysis was not performed because the follow-up period was insufficient to capture enough events. | Posted | Up to 28 Months |
|
|
| 31 |
| 64 |
| 63 |
| 64 |
| EG001 | Idelalisib (Cohort 2) | Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity | 28 | 41 | 40 | 41 |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Cytomegalovirus oesophagitis | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.1 and 19.0 | Systematic Assessment |
|
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:
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Grade ≥ 3 AE |
|
| AE related to idelalisib |
|
| AE leading to permanent drug discontinuation |
|
| % Change at Wk 16 |
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| % Change at Wk 24 |
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| % Change at Wk 36 |
|
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| % Change at Wk 48 |
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| % Change at Wk 60 |
|
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| % Change at Wk 72 |
|
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| % Change at Wk 84 |
|
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| % Change at Wk 96 |
|
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| % Change at Wk 108 |
|
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| % Change at Wk 120 |
|
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| Best % Change |
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| Week 4 predose |
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| Week 4 postdose |
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| Week 24 predose |
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| Week 24 postdose |
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|
|
| Week 4 predose |
|
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| Week 4 postdose |
|
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| Week 8 predose |
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| Week 20 predose |
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