A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT01539512

Recruitment Status : Completed

First Posted : February 27, 2012

Results First Posted : October 16, 2014

Last Update Posted : May 7, 2015

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Chronic Lymphocytic Leukemia	Drug: Idelalisib Drug: Rituximab Drug: Placebo to match idelalisib	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	April 2012
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Rituximab Idelalisib

Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Idelalisib + rituximab Participants will receive idelalisib plus rituximab	Drug: Idelalisib Idelalisib 150 mg tablet administered orally twice daily Other Names: Zydelig® GS-1101 CAL 101 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

Outcome Measures

Primary Outcome Measures :

Progression-Free Survival [ Time Frame: Up to 17 months ]
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.

Secondary Outcome Measures :

Overall Response Rate [ Time Frame: Up to 17 months ]
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.
Lymph Node Response Rate [ Time Frame: Up to 17 months ]
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.
Overall Survival [ Time Frame: Up to 17 months ]
Overall survival was defined as the interval from randomization to death from any cause.
Complete Response Rate [ Time Frame: Up to 17 months ]
Complete response rate was defined as the percentage of participants who achieved a complete response.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539512

Show 72 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators


Study Director:	Thomas Jahn, MD	Gilead Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.


Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01539512 History of Changes
Other Study ID Numbers:	GS-US-312-0116 2011-005180-24 ( EudraCT Number )
First Posted:	February 27, 2012 Key Record Dates
Results First Posted:	October 16, 2014
Last Update Posted:	May 7, 2015
Last Verified:	April 2015

Keywords provided by Gilead Sciences:


CLL CAL-101 GS 1101	PI3K GS-US-312-0117 idelalisib

Additional relevant MeSH terms:


Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases	Leukemia, B-Cell Idelalisib Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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