Phase 2 Completed N=18 Treatment

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

Non-Hodgkin's Lymphoma · Follicular Lymphoma · small lymphocytic lymphoma · Marginal Zone Lymphoma

Source: ClinicalTrials.gov NCT01306643 ↗

Enrolled (actual)

Serious AEs

27.8%

Results posted

Dec 2016

Primary outcomePrimary: Overall Safety of Idelalisib — 88.9; 27.8; 55.6; 83.3 percentage of participants

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.

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.