Phase2 Gilead Study Safety&Efficacy of Idela&Rituximab in CLL patients
Research type
Research Study
Full title
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion
IRAS ID
158390
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2013-003314-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 4 months, 20 days
Research summary
Gilead Sciences, Inc. (Gilead) is conducting a phase 2 study to see how safe and effective it is to add Idelalisib treatment to rituximab in patients with untreated Chronic Lymphocytic Leukaemia with 17p deletion. These patients, who also meet other criteria for treatment, have a poor response to this standard therapy. While the treatment is to try to control the disease manifestation and provide a durable remission, these treatments are not curative. They have a Progression Free Survival of less than 12 months and response rate of about 70%. These treatments are the current standard frontline therapy for fit patients. There is a particular need for treatment that is non-cytotoxic for the population of CLL patients that do not respond well to the intensive chemoimmunotherapy. CLL patients with 17p deletion are in particular need for new targeted therapies.
Idelalisib inhibits growth and survival and promotes death in many B-cell malignancies. Idelalisib has shown to be effective in relapsed/refractory CLL patients in Phase 1 administered alone and also shown excellent activity in another phase 2 study, where it is given in combination with rituximab, in treatment naïve subjects.
Given these results, in the context of the natural history of 17p deletion mutation in CLL, this single-arm Phase 2 study is expected to provide clear results using historical controls.
Treatment with Idelalisib is continuous on this study, with no pre-determined treatment duration. The patients will remain on treatment until definitive progression of their disease, reaction to treatment that requires discontinuation, patient preference to withdraw or death. The study is anticipated to be open for approximately 10 years.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1204
Date of REC Opinion
19 Nov 2014
REC opinion
Further Information Favourable Opinion