Phase 2
N=18
Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
Indolent Non-Hodgkin's Lymphoma · Follicular Lymphoma · Small Lymphocytic Lymphoma · Marginal Zone Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01306643 ↗Enrolled (actual)
18
Serious AEs
27.8%
Results posted
Dec 2016
Primary outcome: Primary: Overall Safety of Idelalisib — 88.9; 27.8; 55.6; 83.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Idelalisib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Safety of Idelalisib |
88.9; 27.8; 55.6; 83.3; 27.8 | — |
| PRIMARY Clinical Response: Overall Response Rate |
44.4 | — |
| SECONDARY Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells |
— | — |
| SECONDARY Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells |
— | — |
| SECONDARY Changes in Concentration of Peripheral Blood Chemokines and Cytokines |
— | — |
| SECONDARY Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01306643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.