Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma
Conditions
Keywords
indolent Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, iNHL, NHL, GS-1101, CAL-101, PI3K, Phosphatidylinositol 3-kinase, Follicular Lymphoma (FL), Small lymphocytic lymphoma (SLL), Lymphoplasmacytoid lymphoma (LPL), Marginal zone lymphoma (MZL)
Brief summary
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.
Interventions
DRUGIdelalisib
Idelalisib 150 mg tablet administered orally twice daily
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group \[ECOG\] performance score of 0, 1, or 2) * Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following: * Follicular lymphoma (FL) * Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration * Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM) * Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal) * Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL * Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy * Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL * Lymphoma that is refractory to rituximab and to an alkylating agent * Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2 * For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods * Willingness and ability to provide written informed consent and to comply with the protocol requirements Key
Exclusion criteria
* Central nervous system or leptomeningeal lymphoma * Known histological transformation from iNHL to diffuse large B-cell lymphoma * History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years * Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment * Pregnancy or breastfeeding * Ongoing alcohol or drug addiction * Known history of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation * Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may be using topical or inhaled corticosteroids. * Prior therapy with idelalisib * Exposure to another investigational drug within 3 weeks prior to start of study treatment * Concurrent participation in another therapeutic treatment trial * Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Start of Treatment to End of Treatment (up to 81 months) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | Start of Treatment to End of Treatment (up to 81 months) | 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 Rate | Start of Treatment to End of Treatment (up to 81 months) | 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 | Start of Treatment to End of Treatment (up to 81 months) | 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 | Start of Treatment to End of Treatment (up to 81 months) | 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. |
| Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) | Baseline to End of Treatment (up to 81 months) | 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. |
| Change in Karnofsky Performance Status | Baseline to End of Treatment (up to 81 months) | 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. |
| Overall Survival | Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years) | 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. |
| Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Start of Treatment to End of Treatment (up to 81 months) plus 30 days | 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. |
| Study Drug Exposure | Start of Treatment to End of Treatment (up to 81 months) | The average idelalisib exposure was summarized. |
| Idelalisib Plasma Concentration | Predose and at 1.5 hours (± 5 minutes) postdose on Day 29 | — |
| PK Parameter: Cmax | Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29 | Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug. |
| PK Parameter: Tmax | Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29 | Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug). |
| PK Parameter: AUClast | Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29 | AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration |
| Changes in Plasma Concentrations of Disease-Associated Chemokines and Cytokines | Enrollment to End of Treatment (up to 81 months) | 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. |
Countries
France, Germany, Italy, Poland, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at a total of 54 study sites in North America and Europe. The first participant was screened on 04 March 2011. The last participant observation was on 16 May 2018.
Pre-assignment details
125 participants were enrolled and treated and comprise the Intent-to-Treat (ITT) Analysis Set.
Participants by arm
| Arm | Count |
|---|---|
| Idelalisib Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity. | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Long-term Follow-up Period (5 Years) | Death | 40 |
| Long-term Follow-up Period (5 Years) | Lost to Follow-up | 1 |
| Long-term Follow-up Period (5 Years) | Other (Unknown) | 21 |
| Long-term Follow-up Period (5 Years) | Withdrew Consent | 2 |
| Treatment Period (TP) (81 Months) | Adverse Event | 30 |
| Treatment Period (TP) (81 Months) | Investigator Request | 7 |
| Treatment Period (TP) (81 Months) | Other (Unknown) | 3 |
| Treatment Period (TP) (81 Months) | Withdrew Consent | 6 |
Baseline characteristics
| Characteristic | Idelalisib |
|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11.4 |
| Baseline Disease History Folicular lymphoma | 72 Participants |
| Baseline Disease History LPL/WM | 10 Participants |
| Baseline Disease History Marginal zone lymphoma | 15 Participants |
| Baseline Disease History Small lymphocytic lymphoma | 28 Participants |
| Karnofsky Performance Status Score = 100 | 46 Participants |
| Karnofsky Performance Status Score = 60 | 2 Participants |
| Karnofsky Performance Status Score = 70 | 6 Participants |
| Karnofsky Performance Status Score = 80 | 27 Participants |
| Karnofsky Performance Status Score = 90 | 44 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Missing | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 117 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants |
| Race/Ethnicity, Customized Race Missing | 1 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 110 Participants |
| Region of Enrollment France | 10 Participants |
| Region of Enrollment Germany | 10 Participants |
| Region of Enrollment Italy | 6 Participants |
| Region of Enrollment Poland | 8 Participants |
| Region of Enrollment United Kingdom | 8 Participants |
| Region of Enrollment United States | 83 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 64 / 125 |
| other Total, other adverse events | 123 / 125 |
| serious Total, serious adverse events | 72 / 125 |
Outcome results
Primary
Overall Response Rate
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)
Time frame: Start of Treatment to End of Treatment (up to 81 months)
Population: ITT Analysis Set included enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Idelalisib | Overall Response Rate | 57.6 percentage of participants |
p-value: <0.0001Exact binomial test
Secondary
Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)
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.
Time frame: Baseline to End of Treatment (up to 81 months)
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idelalisib | Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) | 10.3 units on a scale | Standard Deviation 17.08 |
Secondary
Change in Karnofsky Performance Status
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.
Time frame: Baseline to End of Treatment (up to 81 months)
Population: Participants in the ITT Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | Change in Karnofsky Performance Status | Best change | 3.0 units on a scale | Standard Deviation 8.71 |
| Idelalisib | Change in Karnofsky Performance Status | Worst change | -10.7 units on a scale | Standard Deviation 12.61 |
Secondary
Changes in Plasma Concentrations of Disease-Associated Chemokines and Cytokines
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.
Time frame: Enrollment to End of Treatment (up to 81 months)
Secondary
Duration of Response
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.
Time frame: Start of Treatment to End of Treatment (up to 81 months)
Population: Participants in the ITT Analysis Set who achieved a CR or PR (or MR for participants with WM) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Idelalisib | Duration of Response | 12.5 months |
Secondary
Idelalisib Plasma Concentration
Time frame: Predose and at 1.5 hours (± 5 minutes) postdose on Day 29
Population: Pharmacokinetic (PK) Analysis Set included participants in the ITT Analysis Set who had the necessary baseline and on-study measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | Idelalisib Plasma Concentration | Predose | 471.6 ng/mL | Standard Deviation 486.53 |
| Idelalisib | Idelalisib Plasma Concentration | Postdose | 2187.7 ng/mL | Standard Deviation 1050.76 |
Secondary
Lymph Node Response Rate
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 frame: Start of Treatment to End of Treatment (up to 81 months)
Population: Participants in the ITT Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Idelalisib | Lymph Node Response Rate | 56.8 percentage of participants |
Secondary
Overall Survival
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.
Time frame: Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
Population: Participants in the ITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Idelalisib | Overall Survival | 48.6 months |
Secondary
PK Parameter: AUClast
AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Population: Participants in the PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | PK Parameter: AUClast | AUClast at Day 1 | 9094.76 hours x ng/mL | Standard Deviation 2960.391 |
| Idelalisib | PK Parameter: AUClast | AUClast at Day 29 | 9293.39 hours x ng/mL | Standard Deviation 3996.826 |
Secondary
PK Parameter: Cmax
Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Population: Participants in the PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Idelalisib | PK Parameter: Cmax | Cmax at Day 1 | 2647.5 ng/mL | Standard Deviation 1084.99 |
| Idelalisib | PK Parameter: Cmax | Cmax at Day 29 | 2258.8 ng/mL | Standard Deviation 809.61 |
Secondary
PK Parameter: Tmax
Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).
Time frame: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Population: Participants in the PK Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Idelalisib | PK Parameter: Tmax | Tmax at Day 1 | 1.00 hours |
| Idelalisib | PK Parameter: Tmax | Tmax at Day 29 | 1.00 hours |
Secondary
Progression-Free Survival
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.
Time frame: Start of Treatment to End of Treatment (up to 81 months)
Population: Participants in the ITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Idelalisib | Progression-Free Survival | 11.1 months |
Secondary
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
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.
Time frame: Start of Treatment to End of Treatment (up to 81 months) plus 30 days
Population: Participants in the ITT Analysis Set were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | AE leading to drug discontinuation | 35 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Any AE | 123 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Serious AE | 72 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Vital signs abnormal - clinically meaningful | 0 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | ECG abnormal - clinically meaningful | 0 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Grade 3 or 4 hemoglobin | 2 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Grade 3 or 4 neutrophils | 35 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Grade 3 or 4 platelets | 9 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Grade 3 or 4 alanine aminotransferase | 16 Participants |
| Idelalisib | Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms | Grade 3 or 4 aspartate aminotransferase | 11 Participants |
Secondary
Study Drug Exposure
The average idelalisib exposure was summarized.
Time frame: Start of Treatment to End of Treatment (up to 81 months)
Population: Participants in the ITT Analysis Set were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idelalisib | Study Drug Exposure | 13.2 months | Standard Deviation 15.08 |
Secondary
Time to Response
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.
Time frame: Start of Treatment to End of Treatment (up to 81 months)
Population: Participants in the ITT Analysis Set who achieved a CR or PR (or MR for participants with WM) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Idelalisib | Time to Response | 2.0 months |