Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma
This study will evaluate the efficacy and safety of idelalisib in participants with relapsed of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall response rate.
Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable toxicity.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study to Assess the Efficacy and Safety of GS-1101 (CAL-101) in Patients With Relapsed or Refractory Hodgkin Lymphoma|
- Overall Response Rate [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]
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 proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator.
- 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.
- Duration of Response [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.
- Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically [ Time Frame: Baseline, Week 8, Week 48, and up to Week 110 ] [ Designated as safety issue: No ]
- Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET) [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]
- Time to Response [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.
- Overall Survival [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]Overall survival was defined as the time from start of idelalisib treatment to death from any cause.
- Progression Free Survival [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]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 or death from any cause.
- Time to Treatment Failure [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.
- Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire [ Time Frame: Baseline and up to Week 110 ] [ Designated as safety issue: No ]
Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline.
The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life.
- Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age [ Time Frame: Baseline and up to Week 110 ] [ Designated as safety issue: No ]Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. 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 classifies patients 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.
- Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]
- Overall Safety Profile of Idelalisib [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. "Clinically significant" abnormalities in ECG were as determined by the investigator.
- Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug [ Time Frame: Up to Week 110 ] [ Designated as safety issue: No ]
- Idelalisib Trough and Peak Plasma Concentration at Week 4 [ Time Frame: Predose and 1.5 hours postdose at Week 4 ] [ Designated as safety issue: No ]Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.
|Study Start Date:||September 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Participants will receive up to 300 mg of idelalisib twice daily.
Idelalisib tablets administered orally
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393106
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Director:||Lyndah Dreiling, MD||Gilead Sciences|