Clinical trial NCT01539291: Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
Official title: A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
CAL-101
CAL 101
GS-1101
GS 1101
PI3K
Leukemia
GS-US-312-0116
idelalisib
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.


Eligibility criteria: Key Inclusion Criteria:

* Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
* Tolerating primary study therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation
timeFrame: First IDL dose date in study GS-US-312-0116 or GS-US-312-0117 to last IDL dose date in study GS-US-312-0117 (maximum: 67.3 months) plus 4 weeks
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Lymph Node Response Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Complete Response (CR) Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Time to Response (TTR)
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Duration of Response (DOR)
timeFrame: From first documentation of CR or PR to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Best Percent Change in Lymph Node Area
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Splenomegaly Response Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Hepatomegaly Response Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Absolute Lymphocyte Count (ALC) Response Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Platelet Response Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Hemoglobin Response Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Neutrophil Response Rate
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Overall Survival
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire
timeFrame: Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 184
measure: Best Change From Baseline in Karnofsky Performance Status (KPS)
timeFrame: Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 190
measure: Changes From Baseline in Phosphatidylinositol 3-kinase (PI3Kδ)/Akt/Mammalian Target of Rapamycin (mTOR) Pathway Activation as a Measure of PI3Kδ Pathway Activity
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines
timeFrame: GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)
measure: Study Drug Compliance as Assessed by the Percentage of Participants Adhering to Treatment
timeFrame: First IDL dose date in study GS-US-312-0116 or GS-US-312-0117 to last IDL dose date in study GS-US-312-0117 (maximum: 67.3 months)
measure: Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib
timeFrame: Weeks 4, 12, and 24
measure: Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure
timeFrame: Study GS-US-312-0116 or GS-US-312-0117 Baseline; Weeks 24 and 48
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego - Moores Cancer Center
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Blood and Marrow Transplant Program
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center Lombardi Cancer Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Collaborative Research Group
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Springfield
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Network of South Texas
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Erlangen
country: Germany
facility: Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l.
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Orpington
country: United Kingdom
facility: Princess Royal University Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Coutre SE, Furman RR, Sharman, JP, Cheson BD, Pagel JM, Hillmen P, et al. Second Interim Analysis of a Phase 3 Study of Idelalisib (Zydelig®) Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia: Efficacy Analysis in Patient Subpopulations with Del(17p) and Other Adverse Prognostic Factors. Blood 2014; 124 (21):330
citation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, et al. Efficacy of Idelalisib in CLL Subpopulations Harboring Del(17p) and Other Adverse Prognostic Factors: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Trial [Poster 7011]. American Society of Clinical Oncology (ASCO) 50th Annual Meeting; 2014 May 30-June 3; Chicago, IL. J Clin Oncol 32:5s, 2014 (suppl; abstr 7011)
citation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn IW, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Tausch E, Cramer P, Huang J, Mitra S, Hallek M, O'Brien SM, Stilgenbauer S. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia. J Clin Oncol. 2019 Jun 1;37(16):1391-1402. doi: 10.1200/JCO.18.01460. Epub 2019 Apr 17.