A Phase 3 interventional study of Idelalisib in Follicular Lymphoma, sponsored by Gilead Sciences. Terminated at 66 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment
The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 96 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Participants will receive idelalisib 150 mg twice daily continuously. For participants enrolled prior to protocol amendment 5: Based on the independent review committee (IRC) response assessment, participants may be discontinued from the study or may receive blinded or open-label idelalisib 150 mg twice daily.
Drug: Idelalisib
Participants will receive idelalisib 100 mg twice daily continuously. Based on the IRC response assessment, participants may either be dose escalated to open-label 150 mg twice daily or maintain blind and continue on idelalisib 100 mg twice daily. As of protocol amendment 5, enrollment to this arm has been closed.
Drug: Idelalisib
Participants will receive idelalisib 150 mg twice daily in 28-day cycles with 21 days on-treatment and 7 days off-treatment.
Drug: Idelalisib
Idelalisib tablet administered orally
Also known as: Zydelig®, GS-1101, CAL-101
Overall Response Rate (ORR)
ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Time frame: Randomization up to end of treatment (maximum duration: 73.5 months)
Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced.
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Duration of Response (DOR)
DOR: interval from first documentation of CR/PR to earlier of first documentation of disease progression (PD) by independent review committee (IRC)/death from any cause. PR:No evidence of new disease,≥50% decrease from baseline in SPD of index lesions,no increase in non-index disease, no increase in liver/spleen size,no new liver/spleen enlargement; Persistence of bone marrow involvement in participant who meets other CR criteria. CR: No evidence of new disease,regression of all index nodal lesions to normal size (large nodes:≤1.5 cm in LD;small nodes:≤1.0 cm in LD,≤1.0 cm in LPD), regression to normal of all nodal non-index disease,disappearance of all detectable extra-nodal index,non-index disease,normal spleen and liver size, no new liver/spleen enlargement; PD: New node of \>1.5 cm or \>1.0 to ≤1.5 cm in LD, \>1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion,new non-index disease,increase by 50% in SPD of index lesions,LD of individual node/extra-nodal mass.
Time frame: From first documentation of CR or PR until PD or death from any cause (maximum duration: 73.5 months)
Overall Response Rate (ORR) by Week 24
ORR by Week 24 is defined as the percentage of participants who achieve a PR or CR by Week 24. PR criteria: No evidence of new disease, a 50% decrease from baseline in SPD of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in LD for large nodes and ≤1.0 cm in LD, ≤1.0 cm in LPD for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Time frame: First dose date up to Week 24
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the NCI CTCAE version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants are counted at the highest AE grade experienced.
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days. Laboratory abnormalities included hematology and serum chemistry parameters. Clinically significant laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). The number of participants with any post-baseline abnormal laboratory value in Grade 1-4 categories are reported.
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Time to Onset of Adverse Events of Interest (AEIs)
Time to onset of AEIs is defined as the interval (in months) from the start of idelalisib treatment to the first documentation of start of AEI. AEIs included grade ≥ 3 diarrhea/colitis, rash, febrile neutropenia, infection, and any grade of: Pneumonitis, bowel perforation, progressive multifocal leukoencephalopathy (PML), Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) infection, and organizing pneumonia.
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Progression-Free Survival (PFS)
PFS is defined as the interval (in months) from randomization to the earlier of the first documentation of PD by IRC or death from any cause. PD criteria: New node of \>1.5 cm or \>1.0 cm to ≤1.5 cm in LD, \>1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion, new non-index disease, increase by 50% in SPD of index lesions, LD of individual node/extra-nodal mass.
Time frame: Randomization up to PD or death from any cause (maximum duration: 73.5 months)
Overall Survival (OS)
OS is defined as the interval (in months) from randomization to death from any cause.
Time frame: Randomization up to death from any cause (maximum duration: 73.5 months)
Trough Plasma Concentration of Idelalisib
Time frame: Predose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48
Peak Plasma Concentration of Idelalisib
Time frame: 1.5 hours postdose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48
Participants were enrolled at study sites in Australia, Canada, Europe, Israel, and the United Kingdom.
| Milestone | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Started | 47 | 27 | 22 |
| Completed | 0 | 0 | 0 |
| Not completed | 47 | 27 | 22 |
| Withdrew: Investigator's discretion | 17 | 11 | 2 |
| Withdrew: Progressive disease | 11 | 7 | 6 |
| Withdrew: Study terminated by sponsor | 6 | 4 | 7 |
| Withdrew: Death | 7 | 0 | 5 |
| Withdrew: Withdrew consent | 4 | 2 | 0 |
| Withdrew: Initiation of non-study specific anti-cancer therapy in the absence of progression | 1 | 2 | 1 |
| Withdrew: Enrolled but never treated | 0 | 0 | 1 |
| Withdrew: Non-compliance with study drug | 1 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
| percentage of participants | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Overall Response Rate (ORR) | 38.3 (24.5 to 53.6) | 44.4 (25.5 to 64.7) | 40.9 (20.7 to 63.6) |
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced.
| Participants | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs) | 15 | 12 | 8 |
DOR: interval from first documentation of CR/PR to earlier of first documentation of disease progression (PD) by independent review committee (IRC)/death from any cause. PR:No evidence of new disease,≥50% decrease from baseline in SPD of index lesions,no increase in non-index disease, no increase in liver/spleen size,no new liver/spleen enlargement; Persistence of bone marrow involvement in participant who meets other CR criteria. CR: No evidence of new disease,regression of all index nodal lesions to normal size (large nodes:≤1.5 cm in LD;small nodes:≤1.0 cm in LD,≤1.0 cm in LPD), regression to normal of all nodal non-index disease,disappearance of all detectable extra-nodal index,non-index disease,normal spleen and liver size, no new liver/spleen enlargement; PD: New node of \>1.5 cm or \>1.0 to ≤1.5 cm in LD, \>1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion,new non-index disease,increase by 50% in SPD of index lesions,LD of individual node/extra-nodal mass.
| months | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Duration of Response (DOR) | 27.1 (7.7 to NA) | 18.0 (2.7 to NA) | 5.7 (0.3 to NA) |
ORR by Week 24 is defined as the percentage of participants who achieve a PR or CR by Week 24. PR criteria: No evidence of new disease, a 50% decrease from baseline in SPD of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in LD for large nodes and ≤1.0 cm in LD, ≤1.0 cm in LPD for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
| percentage of participants | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Overall Response Rate (ORR) by Week 24 | 36.2 (22.7 to 51.5) | 33.3 (16.5 to 54.0) | 27.3 (10.7 to 50.2) |
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the NCI CTCAE version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants are counted at the highest AE grade experienced.
| Participants | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Any TEAE | 45 | 26 | 19 |
| Grade 3 or Higher TEAEs | 41 | 25 | 12 |
| Serious TEAEs | 31 | 19 | 11 |
| Idelalisib-related TEAEs | 38 | 25 | 11 |
| TEAEs Leading to Interruption of Idelalisib | 32 | 18 | 6 |
| TEAEs Leading to Discontinuation of Idelalisib | 28 | 13 | 4 |
Treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days. Laboratory abnormalities included hematology and serum chemistry parameters. Clinically significant laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). The number of participants with any post-baseline abnormal laboratory value in Grade 1-4 categories are reported.
| Participants | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Hematology: Grade 1 | 7 | 5 | 2 |
| Hematology: Grade 2 | 12 | 7 | 5 |
| Hematology: Grade 3 | 15 | 11 | 5 |
| Hematology: Grade 4 | 6 | 3 | 2 |
| Serum Chemistry: Grade 1 | 9 | 5 | 8 |
| Serum Chemistry: Grade 2 | 17 | 8 | 4 |
| Serum Chemistry: Grade 3 | 10 | 11 | 6 |
| Serum Chemistry: Grade 4 | 7 | 3 | 1 |
Time to onset of AEIs is defined as the interval (in months) from the start of idelalisib treatment to the first documentation of start of AEI. AEIs included grade ≥ 3 diarrhea/colitis, rash, febrile neutropenia, infection, and any grade of: Pneumonitis, bowel perforation, progressive multifocal leukoencephalopathy (PML), Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) infection, and organizing pneumonia.
No measurements were reported for this outcome.
PFS is defined as the interval (in months) from randomization to the earlier of the first documentation of PD by IRC or death from any cause. PD criteria: New node of \>1.5 cm or \>1.0 cm to ≤1.5 cm in LD, \>1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion, new non-index disease, increase by 50% in SPD of index lesions, LD of individual node/extra-nodal mass.
| months | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Progression-Free Survival (PFS) | 9.8 (5.5 to 28.7) | 19.4 (13.9 to 23.3) | 8.3 (2.9 to 8.7) |
OS is defined as the interval (in months) from randomization to death from any cause.
| months | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Overall Survival (OS) | 28.7 (14.0 to NA) | NA (23.3 to NA) | NA (13.9 to NA) |
| nanograms per milliliter (ng/ml) | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Day 1 | NA ± NA | NA ± NA | NA ± NA |
| Week 2 | 683.68 ± 514.166 | 382.94 ± 352.842 | 636.35 ± 461.042 |
| Week 4 | 623.64 ± 466.557 | 447.78 ± 356.971 | 94.14 ± 231.647 |
| Week 6 | 581.20 ± 470.988 | 361.90 ± 248.996 | 596.80 ± 401.619 |
| Week 8 | 655.16 ± 498.873 | 430.33 ± 477.877 | 77.66 ± 274.313 |
| Week 10 | 616.05 ± 370.862 | 356.12 ± 372.557 | 387.40 ± 314.249 |
| Week 12 | 630.56 ± 664.066 | 389.21 ± 466.104 | 272.44 ± 626.451 |
| Week 16 | 729.23 ± 832.158 | 730.29 ± 936.798 | 111.67 ± 296.666 |
| Week 20 | 525.91 ± 411.330 | 745.58 ± 841.105 | 107.34 ± 269.434 |
| Week 24 | 460.74 ± 321.766 | 728.76 ± 760.391 | NA ± NA |
| Week 32 | 446.13 ± 450.821 | 388.58 ± 351.293 | 352.73 ± 875.923 |
| Week 48 | 706.13 ± 580.022 | 552.13 ± 571.081 | 165.00 ± 368.951 |
| ng/ml | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| Day 1 | 2626.12 ± 1330.290 | 1575.81 ± 803.317 | 2221.35 ± 1621.291 |
| Week 2 | 2306.12 ± 810.433 | 1520.29 ± 675.089 | 2186.89 ± 1265.850 |
| Week 4 | 2353.95 ± 930.754 | 1528.48 ± 759.936 | 2608.12 ± 1009.937 |
| Week 6 | 2433.33 ± 1092.969 | 1682.52 ± 939.455 | 2341.33 ± 948.133 |
| Week 8 | 2207.59 ± 980.606 | 1649.25 ± 940.683 | 2786.43 ± 1591.408 |
| Week 10 | 2435.00 ± 1027.469 | 1601.11 ± 804.605 | 2380.00 ± 1118.679 |
| Week 12 | 2328.13 ± 1141.764 | 1658.89 ± 837.159 | 2316.20 ± 1391.815 |
| Week 16 | 2634.39 ± 1323.611 | 1756.37 ± 826.784 | 2372.50 ± 1335.420 |
| Week 20 | 2354.26 ± 1440.587 | 1925.29 ± 776.516 | 2177.69 ± 1417.505 |
| Week 24 | 2058.47 ± 905.071 | 1914.65 ± 1151.998 | 1906.30 ± 1099.458 |
| Week 32 | 2009.71 ± 1231.296 | 2028.00 ± 593.236 | 1825.00 ± 947.892 |
| Week 48 | 2655.13 ± 1348.957 | 1448.33 ± 650.798 | 1312.00 ± 850.894 |
Collected over All-Cause Mortality: Enrollment up to last follow up visit (maximum 73.5 months); Adverse Events: First dose date up to 30 days after last dose of study drug (maximum 64.6 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Idelalisib 150 mg BID | 20/47 (42.6%) | 31/47 (66%) | 44/47 (93.6%) |
| Idelalisib 100 mg BID | 12/27 (44.4%) | 19/27 (70.4%) | 24/27 (88.9%) |
| Idelalisib 150 mg BID INT | 6/22 (27.3%) | 11/21 (52.4%) | 16/21 (76.2%) |
| Event | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 7/47 | 6/27 | 0/21 |
| Acute kidney injuryRenal and urinary disorders | 0/47 | 4/27 | 0/21 |
| Covid-19Infections and infestations | 1/47 | 1/27 | 2/21 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/47 | 2/27 | 0/21 |
| PneumoniaInfections and infestations | 1/47 | 2/27 | 1/21 |
| ColitisGastrointestinal disorders | 3/47 | 0/27 | 0/21 |
| AnaemiaBlood and lymphatic system disorders | 2/47 | 0/27 | 1/21 |
| PyrexiaGeneral disorders | 1/47 | 0/27 | 1/21 |
| Abdominal infectionInfections and infestations | 0/47 | 0/27 | 1/21 |
| Covid-19 pneumoniaInfections and infestations | 1/47 | 0/27 | 1/21 |
| Event | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 19/47 | 12/27 | 6/21 |
| NeutropeniaBlood and lymphatic system disorders | 12/47 | 10/27 | 4/21 |
| RashSkin and subcutaneous tissue disorders | 11/47 | 4/27 | 6/21 |
| PyrexiaGeneral disorders | 11/47 | 6/27 | 3/21 |
| NauseaGastrointestinal disorders | 5/47 | 6/27 | 4/21 |
| Aspartate aminotransferase increasedInvestigations | 8/47 | 6/27 | 0/21 |
| AnaemiaBlood and lymphatic system disorders | 10/47 | 3/27 | 2/21 |
| Alanine aminotransferase increasedInvestigations | 9/47 | 5/27 | 0/21 |
| VomitingGastrointestinal disorders | 4/47 | 5/27 | 1/21 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/47 | 4/27 | 0/21 |
Safety analysis set included all participants who received at least 1 dose of study drug.
| Age, Categorical(Participants) | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 14 | 11 | 45 |
| >=65 years | 27 | 13 | 10 | 50 |
| Age, Continuous(years) | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT | Total |
|---|---|---|---|---|
| Mean | 65 ± 13.0 | 62 ± 13.6 | 63 ± 11.6 | 64 ± 12.8 |
| Sex: Female, Male(Participants) | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT | Total |
|---|---|---|---|---|
| Female | 23 | 13 | 8 | 44 |
| Male | 24 | 14 | 13 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 2 | 3 |
| Not Hispanic or Latino | 42 | 26 | 17 | 85 |
| Unknown or Not Reported | 4 | 1 | 2 | 7 |
| Race/Ethnicity, Customized(Participants) | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT | Total |
|---|---|---|---|---|
| Race — White | 42 | 25 | 18 | 85 |
| Race — Unknown or Not Reported | 4 | 1 | 2 | 7 |
| Race — Asian | 1 | 0 | 0 | 1 |
| Race — Black or African American | 0 | 0 | 1 | 1 |
| Race — Other or More Than One Race | 0 | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Idelalisib 150 mg BID | Idelalisib 100 mg BID | Idelalisib 150 mg BID INT | Total |
|---|---|---|---|---|
| Italy | 10 | 5 | 4 | 19 |
| Poland | 8 | 6 | 4 | 18 |
| Spain | 8 | 4 | 6 | 18 |
| United Kingdom | 6 | 5 | 4 | 15 |
| France | 5 | 2 | 2 | 9 |
| Czechia | 4 | 3 | 1 | 8 |
| Israel | 4 | 0 | 0 | 4 |
| Australia | 0 | 2 | 0 | 2 |
| Canada | 1 | 0 | 0 | 1 |
| Romania | 1 | 0 | 0 | 1 |
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