Indolent Non-Hodgkin's LymphomaPhase 1/2NCT01306643
Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
A Phase 1/2 study testing Idelalisib in people with Indolent Non-Hodgkin's Lymphoma and Follicular Lymphoma, run by Gilead Sciences at 2 sites in United States.
Trial summary
The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL). Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma
- What is being tested?
- Idelalisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Aug 2015
- Phase
- Phase 1/2
- 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
- Previously treated relapsed or refractory B-cell iNHL
- Provide written informed consent
Who cannot join
- Pregnant or nursing
- Active, serious infection requiring systemic therapy
- Positive test for HIV antibodies
- Active hepatitis B or C viral infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai School of Medicine
New York, New York, 10029
Stanford Cancer Center
Palo Alto, California, 94304-5548
About this study
Official title: Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events
The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL).
Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.
- Conditions
- Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma
- Being tested
- Idelalisib
- Keywords
- Indolent Non-Hodgkin's Lymphoma, Non-Hodgkin Lymphoma, iNHL, NHL, CAL-101, PI3K, Phosphatidylinositol 3-kinase, Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), Marginal Zone Lymphoma (MZL)
- Medical subject headings
- Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Also called GS-1101, CAL-101, Zydelig®
Tablet(s) administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib | Experimental | Not described Receives: Drug: Idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety of Idelalisib
The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Measured: 30 days post last study treatment (up to 12 months)
Clinical Response: Overall Response Rate
Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.
Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.
- CR was defined as the disappearance of all evidence of disease.
- PR was defined the regression of measurable disease and no new sites.
Measured: Up to twelve 28-day cycles (maximum of 12 months)
Secondary outcomes (4)
Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells
Measured: Up to twelve 28-day cycles (maximum of 12 months)
Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells
Measured: Up to twelve 28-day cycles (maximum of 12 months)
Changes in Concentration of Peripheral Blood Chemokines and Cytokines
Measured: Up to twelve 28-day cycles (maximum of 12 months)
Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast
Measured: Up to twelve 28-day cycles (maximum of 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2015
- Study completionAug 2015
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 Indolent Non-Hodgkin's 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01306643
- Sponsor's protocol ID
- 101-10
- Status last verified
- Oct 2016
- First submitted
- 25 Feb 2011
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events
- ClinicalTrials.gov ID
- NCT01306643
- Acronym / sponsor ID
- 101-10
- Conditions
- Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma
- Keywords
- Indolent Non-Hodgkin's Lymphoma, Non-Hodgkin Lymphoma, iNHL, NHL, CAL-101, PI3K, Phosphatidylinositol 3-kinase, Follicular Lymphoma (FL)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Posted 21 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL).
Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idelalisib | Experimental | Drug: Idelalisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previously treated relapsed or refractory B-cell iNHL
- Provide written informed consent
Key exclusion criteria (4 listed)
- Pregnant or nursing
- Active, serious infection requiring systemic therapy
- Positive test for HIV antibodies
- Active hepatitis B or C viral infection
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: GS-1101, CAL-101, Zydelig®Tablet(s) administered orally twice daily | Drug | Idelalisib |
Primary outcome
Overall Safety of Idelalisib
Time frame: 30 days post last study treatment (up to 12 months)
The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Clinical Response: Overall Response Rate
Time frame: Up to twelve 28-day cycles (maximum of 12 months)
Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12. Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment. * CR was defined as the disappearance of all evidence of disease. * PR was defined the regression of measurable disease and no new sites.
4 secondary outcomes
Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells
Time frame: Up to twelve 28-day cycles (maximum of 12 months)
Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells
Time frame: Up to twelve 28-day cycles (maximum of 12 months)
Changes in Concentration of Peripheral Blood Chemokines and Cytokines
Time frame: Up to twelve 28-day cycles (maximum of 12 months)
Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast
Time frame: Up to twelve 28-day cycles (maximum of 12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Idelalisib in people with Indolent Non-Hodgkin's Lymphoma and Follicular Lymphoma, run by Gilead Sciences at 2 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 21 Dec 2016). 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 Safety of Idelalisib (time frame: 30 days post last study treatment (up to 12 months)). The study lists 2 primary outcomes in all. 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 19 Nov 2018.