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NCT01732926: Bridalveil
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Phase 3 trial testing Idelalisib in Indolent Non-Hodgkin's Lymphomas in 475 participants. Terminated before completion.
17 May 2016
Quick facts
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 475 |
| Start date | 2 January 2013 |
| Primary completion | 17 May 2016 |
| Estimated completion | 17 May 2016 |
| Sites | 144 locations across France, Italy, Russia, Sweden, Taiwan, United Kingdom, Germany, Israel |
Drugs / interventions tested
- Idelalisib — full drug profile →
- Rituximab — full drug profile →
- Bendamustine (BENDAMUSTINE) — full drug profile →
- Placebo
Conditions studied
- Indolent Non-Hodgkin's Lymphomas — all drugs for Indolent Non-Hodgkin's Lymphomas →
Sponsor
Gilead Sciences — full company profile →
Who can join
18 and older, any sex, with Indolent Non-Hodgkin's Lymphomas. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 34 months plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (246 terms)
| Reaction | System | Idelalisib + Bendamustine … | Placebo + Bendamustine + R… |
|---|---|---|---|
| Pyrexia | General disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Pneumocystis jirovecii pneumonia | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Cytomegalovirus infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
Other adverse events (60 terms — click to expand)
| Reaction | System | Idelalisib + Bendamustine … | Placebo + Bendamustine + R… |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Asthenia | General disorders | — | — |
| Weight decreased | Investigations | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Mucosal inflammation | General disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Mouth ulceration | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Pyrexia, Febrile neutropenia, Pneumonia, Rash, Pneumonitis, Diarrhoea, Alanine aminotransferase increased, Aspartate aminotransferase increased.
Data from ClinicalTrials.gov NCT01732926 adverse events section.
Sponsor's own description
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1 -
Therapeutic Modulation of Autophagy in Leukaemia and Lymphoma.
Djavaheri-Mergny M, Giuriato S, Tschan MP, Humbert M. · · 2019 · cited 34× · PMID 30704144 · DOI 10.3390/cells8020103 -
Phosphoinositide 3-kinase inhibitors in lymphoma.
Curran E, Smith SM. · · 2014 · cited 32× · PMID 25024054 · DOI 10.1097/cco.0000000000000113 -
Splenic marginal zone lymphoma: a literature review of diagnostic and therapeutic challenges.
Santos TSD, Tavares RS, Farias DLC. · · 2017 · cited 30× · PMID 28577652 · DOI 10.1016/j.bjhh.2016.09.014 -
Idelalisib for the treatment of non-Hodgkin lymphoma.
Graf SA, Gopal AK. · · 2016 · cited 24× · PMID 26818003 · DOI 10.1517/14656566.2016.1135130 -
Idelalisib for the treatment of indolent non-Hodgkin lymphoma: a review of its clinical potential.
Barrientos JC. · · 2016 · cited 19× · PMID 27274288 · DOI 10.2147/ott.s102573 -
Combinations of idelalisib with rituximab and/or bendamustine in patients with recurrent indolent non-Hodgkin lymphoma.
de Vos S, Wagner-Johnston ND, Coutre SE, Flinn IW, et al · · 2016 · cited 18× · PMID 29296805 · DOI 10.1182/bloodadvances.2016000976 -
Novel Targeted Agents in Hodgkin and Non-Hodgkin Lymphoma Therapy.
Grover NS, Park SI. · · 2015 · cited 15× · PMID 26393619 · DOI 10.3390/ph8030607
Verify or expand the search:
- PubMed search for NCT01732926
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Gilead Sciences trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01732926 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
- Last refreshed: 16 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01732926.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing