A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
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Purpose
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Idelalisib Drug: Rituximab Drug: Placebo to match idelalisib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia |
- Progression-Free Survival [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
Interim data is presented.
- Overall Response Rate [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]
Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.
Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.
Interim data is presented.
- Lymph Node Response Rate [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
Interim data is presented.
- Overall Survival [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]
Overall survival was defined as the interval from randomization to death from any cause.
Interim data is presented.
- Complete Response Rate [ Time Frame: Up to 17 months ] [ Designated as safety issue: No ]
Complete response rate was defined as the percentage of participants who achieved a complete response.
Interim data is presented.
| Enrollment: | 220 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | February 2019 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Idelalisib + rituximab
Participants will receive idelalisib plus rituximab
|
Drug: Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Other Names:
Drug: Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
Other Name: Rituxan®
|
|
Placebo Comparator: Placebo + rituximab
Participants will receive placebo to match idelalisib plus rituximab
|
Drug: Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
Other Name: Rituxan®
Drug: Placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
- Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy
- Require therapy for CLL
- Have experienced CLL progression < 24 months since the completion of the last prior therapy
- Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01539512
Show 72 Study Locations
| Study Director: | Thomas Jahn, MD | Gilead Sciences |
More Information
No publications provided by Gilead Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01539512 History of Changes |
| Other Study ID Numbers: | GS-US-312-0116, 2011-005180-24 |
| Study First Received: | February 12, 2012 |
| Results First Received: | October 9, 2014 |
| Last Updated: | February 6, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
CLL CAL-101 GS 1101 |
PI3K GS-US-312-0117 idelalisib |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Immune System Diseases Immunoproliferative Disorders Leukemia, B-Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms |
Neoplasms by Histologic Type Rituximab Antineoplastic Agents Antirheumatic Agents Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015