Follicular LymphomaPhase 2NCT02258529
Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
A Phase 2 study testing Idelalisib and Rituximab in people with Follicular Lymphoma and Small Lymphocytic Lymphoma, run by Gilead Sciences at 6 sites in United States.
Trial summary
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Small Lymphocytic Lymphoma
- What is being tested?
- Idelalisib and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Sep 2015to 3 May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of B-cell lymphoma
- No previous systemic treatment for lymphoma
- Subject demonstrates need for treatment for lymphoma
- Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
- Adequate performance status
- Required baseline laboratory data within protocol-specified parameters
Who cannot join
- Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
- Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
- Ongoing inflammatory bowel disease
- Known human immunodeficiency virus (HIV) infection
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- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
St. Agnes Hospital
Baltimore, Maryland, 21229
Florida Cancer Specialists
Fort Myers, Florida, 33916
Pacific Shores Medical Group
Long Beach, California, 90813
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Prarie Lakes Health Care Systems, Inc.
Watertown, South Dakota, 57201
About this study
Official title: A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (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 those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
- Conditions
- Follicular Lymphoma, Small Lymphocytic Lymphoma
- Being tested
- Idelalisib, Rituximab
- Keywords
- Cancer, Indolent Non-Hodgkin Lymphoma, FL, SLL
- Medical subject headings
- Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Also called Zydelig®, GS-1101
150 tablets administered orally twice daily
RituximabBiological
Also called Rituxan®, MabThera®
375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib + rituximab | Experimental | Idelalisib + rituximab for up to 104 weeks Receives: Drug: Idelalisib; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
Secondary outcomes (8)
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Measured: Up to 24 weeks plus 30 days
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.
Measured: Up to 24 weeks plus 30 days
Idelalisib Trough and Peak Plasma Concentrations
Measured: Predose and 1.5 hour postdose at Weeks 2, 4, and 12
Time to Response
Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.
Duration of Response
Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.
Progression-Free Survival
Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.
Overall Survival
Overall survival was defined as the interval from enrollment to death from any cause.
Changes in Health-Related Quality of Life
Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study start14 Sep 2015
- Primary completion12 Apr 2016
- Study completion3 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258529
- Sponsor's protocol ID
- GS-US-313-1414
- Status last verified
- Apr 2017
- First submitted
- 3 Oct 2014
- Last updated
- 14 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT02258529
- Acronym / sponsor ID
- GS-US-313-1414
- Conditions
- Follicular Lymphoma, Small Lymphocytic Lymphoma
- Keywords
- Cancer, Indolent Non-Hodgkin Lymphoma, FL, SLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 12 Apr 2016 (actual)
- Study completion
- 3 May 2016 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (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 those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idelalisib + rituximab | Experimental | Drug: Idelalisib, Biological: RituximabIdelalisib + rituximab for up to 104 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of B-cell lymphoma
- No previous systemic treatment for lymphoma
- Subject demonstrates need for treatment for lymphoma
- Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
Key exclusion criteria (9 listed)
- Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
- Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
- Ongoing inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdelalisibAlso: Zydelig®, GS-1101150 tablets administered orally twice daily | Drug | Idelalisib + rituximab |
| RituximabAlso: Rituxan®, MabThera®375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100) | Biological | Idelalisib + rituximab |
Primary outcome
Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).
8 secondary outcomes
Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Time frame: Up to 24 weeks plus 30 days
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
Time frame: Up to 24 weeks plus 30 days
Idelalisib Trough and Peak Plasma Concentrations
Time frame: Predose and 1.5 hour postdose at Weeks 2, 4, and 12
Time to Response
Duration of Response
Progression-Free Survival
Overall Survival
Changes in Health-Related Quality of Life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Idelalisib and Rituximab in people with Follicular Lymphoma and Small Lymphocytic Lymphoma, run by Gilead Sciences at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.