TriangleNCT01732926 · CITED IN SOURCE DOCUMENTS
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- TERMINATED
- Registry last update
- 2018-11-16
The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: * Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following 1. Follicular lymphoma (FL) Grade 1, 2, or 3a 2. Small lymphocytic lymphoma (SLL) 3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM) 4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal) Key Exclusion Criteria: * History of lymphoid malignancy other than those allowed per inclusion criteria. * Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension. * Prior treatment with bendamustine that was not effective. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive rituximab + bendamustine + idelalisib.
- intervention Names
- Drug: Idelalisib
- Drug: Rituximab
- Drug: Bendamustine
- label
- Rituximab + Bendamustine + Idelalisib
- type
- EXPERIMENTAL
- description
- Participants will receive rituximab + bendamustine + placebo.
- intervention Names
- Drug: Rituximab
- Drug: Bendamustine
- Drug: Placebo
- label
- Rituximab + Bendamustine + Placebo
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Rituximab + Bendamustine + Idelalisib
- description
- 150 mg tablet administered orally twice daily
- name
- Idelalisib
- other Names
- Zydelig®
- CAL-101
- GS-1101
- type
- DRUG
- arm Group Labels
- Rituximab + Bendamustine + Idelalisib
- Rituximab + Bendamustine + Placebo
- description
- 375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
- name
- Rituximab
- other Names
- Rituxan®
- MabThera®
- type
- DRUG
- arm Group Labels
- Rituximab + Bendamustine + Idelalisib
- Rituximab + Bendamustine + Placebo
- description
- 90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
- name
- Bendamustine
- other Names
- Treanda®
- type
- DRUG
- arm Group Labels
- Rituximab + Bendamustine + Placebo
- description
- Tablet administered orally twice daily
- name
- Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 475
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
- measure
- Progression-free Survival (PFS)
- secondary Outcomes
- description
- Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
- measure
- Complete Response Rate (CR)
- description
- Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.
- measure
- Overall Response Rate (ORR)
- description
- Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
- measure
- Lymph Node Response Rate
- description
- Overall survival is defined as the interval from randomization to death from any cause.
- measure
- Overall Survival (OS)
Full study description
- brief Summary
- The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Source references
Source notices and limitations
Discovery and provenance
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- occurrences
- context exact
- rom macroglobulinemia (WM) 6%] received 8 doses of R with or without Zydelig 150 mg twice daily. Patients had a median of one prior therapy. In Study 313-0125 (NCT01732926), 475 patients with previously treated iNHL (FL 63%, MZL 15%, SLL 11%, LPL/WM 11%) received up to 6 cycles of BR with or without Zydelig 150 mg twice daily. Pa
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Preserved source evidence · Not medical advice