Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma

Study Overview
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Brief Summary
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The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL). Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.

Official Title
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Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events

Conditions
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Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma

Intervention / Treatment
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* Drug: Idelalisib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously treated relapsed or refractory B-cell iNHL Provide written informed consent Exclusion Criteria: Pregnant or nursing Active, serious infection requiring systemic therapy Positive test for HIV antibodies Active hepatitis B or C viral infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idelalisib<br> | Drug: Idelalisib<br>* Tablet(s) administered orally twice daily<br>* Other names: Zydelig®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety of Idelalisib | The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib). | 30 days post last study treatment (up to 12 months) | 
| Clinical Response: Overall Response Rate | Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12. Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment. CR was defined as the disappearance of all evidence of disease. PR was defined the regression of measurable disease and no new sites. | Up to twelve 28-day cycles (maximum of 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells |  | Up to twelve 28-day cycles (maximum of 12 months) | 
| Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells |  | Up to twelve 28-day cycles (maximum of 12 months) | 
| Changes in Concentration of Peripheral Blood Chemokines and Cytokines |  | Up to twelve 28-day cycles (maximum of 12 months) | 
| Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast |  | Up to twelve 28-day cycles (maximum of 12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, Indolent Non-Hodgkin's Lymphoma, Non-Hodgkin Lymphoma, iNHL, CAL-101, PI3K, Phosphatidylinositol 3-kinase, Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), Marginal Zone Lymphoma (MZL)