Phase 3
Completed N=416
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Source: ClinicalTrials.gov NCT01569295 ↗Enrolled (actual)
416
Serious AEs
59.1%
Results posted
Feb 2018
Primary outcomePrimary: Progression-Free Survival (PFS) — 21.8; 11.1 months — p=< 0.0001
◆ Published Evidence
Highly cited
247citations · ~27 / year
Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.
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)
Linked Publications (2)
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Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.
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Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
21.8; 11.1 | < 0.0001 sig |
| SECONDARY Overall Response Rate (ORR) |
70.0; 45.5 | <0.0001 sig |
| SECONDARY Lymph Node Response Rate |
96.9; 60.9 | <0.0001 sig |
| SECONDARY Overall Survival |
56.2; 42.6 | 0.098 |
| SECONDARY Complete Response Rate |
4.3; 0.5 | 0.011 sig |
Eligibility Criteria
Key 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.
Data sourced from ClinicalTrials.gov (NCT01569295) and the linked publication. 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.