Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

Phase 3

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Idelalisib; Drug: Rituximab; Drug: Bendamustine; Drug: Placebo to match idelalisib

• Registration Number: NCT01569295
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Study Start: 2012-06-15
• Disposition First Submitted: 2016-05-24
• Disposition First Submitted QC: 2016-05-24
• Disposition First Posted: 2016-06-06
• Results First Submitted: 2017-12-18
• Results First Submitted QC: 2018-01-29
• Results First Posted: 2018-02-27
• Primary Completion: 2019-06-10
• Study Completion: 2019-06-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

• Previously treated recurrent CLL
• Measurable lymphadenopathy
• Requires therapy for CLL
• Has experienced CLL progression < 36 months since the completion of the last prior therapy

Key

Exclusion Criteria

• Recent history of a major non-CLL malignancy
• Evidence of an ongoing infection
• CLL refractory to bendamustine
• Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Idelalisib+bendamustine+rituximab	Rituximab	Participants will receive idelalisib plus bendamustine and rituximab
Idelalisib+bendamustine+rituximab	Idelalisib	Participants will receive idelalisib plus bendamustine and rituximab
Idelalisib+bendamustine+rituximab	Bendamustine	Participants will receive idelalisib plus bendamustine and rituximab
Placebo to match idelalisib+bendamustine+rituximab	Rituximab	Participants will receive placebo to match idelalisib plus bendamustine and rituximab
Placebo to match idelalisib+bendamustine+rituximab	Bendamustine	Participants will receive placebo to match idelalisib plus bendamustine and rituximab
Placebo to match idelalisib+bendamustine+rituximab	Placebo to match idelalisib	Participants will receive placebo to match idelalisib plus bendamustine and rituximab

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 84 months	PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to 84 months	ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy.; PR 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. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.
Lymph Node Response Rate	Up to 84 months	Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
Overall Survival	Up to 84 months	Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
Complete Response Rate	Up to 84 months	Complete response (CR) rate was defined as the percentage of participants who achieved a CR.

Trial Locations

Locations (104)

Clearview Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford Cancer Center; 🇺🇸 Palo Alto, California, United States

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Winship Cancer Institute at Emory University; 🇺🇸 Atlanta, Georgia, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Summit Medical Group, P.A.; 🇺🇸 Morristown, New Jersey, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

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