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NCT01732913: Yosemite
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Phase 3 trial testing Placebo in Indolent Non-Hodgkin's Lymphomas in 295 participants. Terminated before completion.
18 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 | 295 |
| Start date | 16 January 2013 |
| Primary completion | 18 May 2016 |
| Estimated completion | 18 May 2016 |
| Sites | 103 locations across Italy, Japan, Taiwan, Poland, South Korea, Russia, Sweden, Portugal |
Drugs / interventions tested
- Placebo
- Rituximab — full drug profile →
- Idelalisib — full drug profile →
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 27 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 (110 terms)
| Reaction | System | Idelalisib + Rituximab | Placebo + Rituximab |
|---|---|---|---|
| Pneumonia | Infections and infestations | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Drug-induced liver injury | Hepatobiliary disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — |
| Asthenia | General disorders | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Cytomegalovirus infection | Infections and infestations | — | — |
Other adverse events (40 terms — click to expand)
| Reaction | System | Idelalisib + Rituximab | Placebo + Rituximab |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — |
| Headache | Nervous system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Weight decreased | Investigations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Asthenia | General disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Transaminases increased | Investigations | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Chills | General disorders | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Pneumonia, Diarrhoea, Alanine aminotransferase increased, Aspartate aminotransferase increased, Pyrexia, Colitis, Pneumonitis, Febrile neutropenia.
Data from ClinicalTrials.gov NCT01732913 adverse events section.
Sponsor's own description
The primary objective of this study is to evaluate the effect of the addition of idelalisib to 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):
-
Current clinical regulation of PI3K/PTEN/Akt/mTOR signalling in treatment of human cancer.
Lim HJ, Crowe P, Yang JL. · · 2015 · cited 131× · PMID 25146530 · DOI 10.1007/s00432-014-1803-3 -
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 -
The PI3K∂-Selective Inhibitor Idelalisib Induces T- and NK-Cell Dysfunction Independently of B-Cell Malignancy-Associated Immunosuppression.
Rohrbacher L, Brauchle B, Ogrinc Wagner A, von Bergwelt-Baildon M, et al · · 2021 · cited 15× · PMID 33790890 · DOI 10.3389/fimmu.2021.608625
Verify or expand the search:
- PubMed search for NCT01732913
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01732913 (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/NCT01732913.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing