Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Idelalisib

Enzyme Inhibitors

Participants will receive up to 300 mg of idelalisib twice daily.

Lyndah Dreiling, MD

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.

Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

A Phase 2 Study to Assess the Efficacy and Safety of GS-1101 (CAL-101) in Patients With Relapsed or Refractory Hodgkin Lymphoma

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.

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 (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.

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 was defined as the time from start of idelalisib treatment to death from any cause.

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 (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.

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 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.

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.

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.

Gilead Sciences

Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.

Age, Continuous

Sex: Female, Male

Asian

Black or African American

White

Other

Race/Ethnicity, Customized

Hispanic or Latino

Not Hispanic or Latino

Time Since Diagnosis (years)

Nodular Sclerosis

Lymphocyte Rich

Classical Hodgkin Lymphoma Pathologic Subtype

Stage I

Stage II

Stage III

Stage IV

Disease stage was based on the Ann Arbor Lymphoma Staging System:

Stage I: Single lymph node group or lymph node region; Stage II: Two or more node regions on same side of diaphragm; Stage III: Lymph node regions on both sides of the diaphragm; Stage IV: Multiple extranodal sites or lymph nodes and extranodal sites

Disease Stage at Screening

Classifies patients according to their functional impairment. Scores range from 0-100; the lower the score, the worse the survival for most serious illnesses.

Karnofsky Performance Status

Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.

There were no limitations affecting the analysis or results.

Clinical Trial Disclosures

Overall Response Rate

Responding Analysis Set: participants who achieved a best response of CR or PR.

Duration of Response

Percent Change at Week 8 (n = 24)

Percent Change at Week 48 (n = 5)

Best Percent Change from Baseline (n = 24)

Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically

An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples.

Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)

Time to Response

Overall Survival

Progression Free Survival

No data are presented because time to treatment failure data were not collected.

Time to Treatment Failure

FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint.

Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire

Best Change

Worst Change

Participants in the ITT Analysis Set with available data were analyzed.

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

This analysis was not conducted due to discrepancies with the transfer of samples.

Spots Global Cancer Trial Database for Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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