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Follicular LymphomaPhase 2DELTANCT01282424

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas

A Phase 2 study testing Idelalisib in people with Follicular Lymphoma and Small Lymphocytic Lymphoma, run by Gilead Sciences at 41 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
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
125 participants
Where
41 sitesin 6 countries
Study dates
18 Mar 2011to 16 May 2018
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

  • Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group [ECOG] performance score of 0, 1, or 2)
  • Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
  • Follicular lymphoma (FL)
  • Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration
  • Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM)
  • Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
Show all 13Show fewer
  • Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL
  • Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
  • Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL
  • Lymphoma that is refractory to rituximab and to an alkylating agent
  • Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2
  • For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods
  • Willingness and ability to provide written informed consent and to comply with the protocol requirements

Who cannot join

  • Central nervous system or leptomeningeal lymphoma
  • Known histological transformation from iNHL to diffuse large B-cell lymphoma
  • History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years
  • Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment
  • Pregnancy or breastfeeding
  • Ongoing alcohol or drug addiction
Show all 14Show fewer
  • Known history of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may be using topical or inhaled corticosteroids.
  • Prior therapy with idelalisib
  • Exposure to another investigational drug within 3 weeks prior to start of study treatment
  • Concurrent participation in another therapeutic treatment trial
  • Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

41 sites in 6 countries.

41 sites in 6 countries

United States22 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30322-1013

  • Collaborative Research Group, LLC

    Boynton Beach, Florida, 33435

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Chattanooga Hem/Oncology Ass (SCRI)

    Chattanooga, Tennessee, 37404

  • Northwestern University Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • St. Jude Medical Center

    Fullerton, California, 92835

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Pacific Shores Medical Group

    Long Beach, California, 90813-3244

  • UCLA

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792-5156

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • University of Medicine and Dentistry of NJ

    New Brunswick, New Jersey, 08901-1914

  • Weill Cornell -New York Presbyterian Hospital

    New York, New York, 10002

  • Montefiore Medical Center

    New York, New York, 10467

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Cancer Center

    Stanford, California, 94035-5796

Other trials in United States

United Kingdom5 sites

  • St James's Institute of Oncology

    Leeds, LS9 7TF

  • St Bartholemews Hospital

    London, EC1M 6BQ

  • Sarah Cannon Institute

    London, W1G 6AD

  • The Christie Hospital

    Manchester, M20 4BX

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

France4 sites

  • CHU Morvan

    Brest, 29609

  • Centre Hospitalier de Lyon Sud

    Pierre-Bénite, 69310

  • Centre Henri Bequerel

    Rouen, 76038

  • CHU Bretonneau - Centre Kaplan

    Tours, 37044

Other trials in France

Germany4 sites

  • Charité Campus Virchow Klinikum

    Berlin, 13353

  • Universitätsklinikum Essen

    Essen, 45147

  • Klinikum der Universität München-Großhadern

    München, 81377

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy4 sites

  • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

    Bologna, 40138

  • A.O.U. San Martino

    Genova, 16132

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

  • Università "Sapienza"

    Rome, 00161

Other trials in Italy

Poland2 sites

  • Małopolskie Centrum Medyczne

    Krakow, 30-510

  • Centrum Onkologii w Warszawie

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents

The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy.

Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.

Being tested
Idelalisib
Keywords
indolent Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, iNHL, NHL, GS-1101, CAL-101, PI3K, Phosphatidylinositol 3-kinase, Follicular Lymphoma (FL), Small lymphocytic lymphoma (SLL), Lymphoplasmacytoid lymphoma (LPL), Marginal zone lymphoma (MZL)
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Non-Hodgkin, Waldenstrom Macroglobulinemia

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, CAL-101, IDELA

    Idelalisib 150 mg tablet administered orally twice daily

Study groups in NCT01282424
Study groupRoleWhat they receive
IdelalisibExperimentalTreatment with idelalisib will be continued until tumor progression or development of unacceptable toxicity.
Receives: Drug: Idelalisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response [MR] for participants with WM) as assessed by the study independent review committee (IRC).

    CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

    PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.

    For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)

    Measured: Start of Treatment to End of Treatment (up to 81 months)

Secondary outcomes (14)

  1. Duration of Response

    Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.

    Measured: Start of Treatment to End of Treatment (up to 81 months)

  2. Lymph Node Response Rate

    Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.

    Measured: Start of Treatment to End of Treatment (up to 81 months)

  3. Time to Response

    Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.

    Measured: Start of Treatment to End of Treatment (up to 81 months)

  4. 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 as assessed by the study IRC or death from any cause. PFS was analyzed using KM estimates.

    Measured: Start of Treatment to End of Treatment (up to 81 months)

  5. Overall Survival

    Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause. OS was analyzed using KM estimates.

    Measured: Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years)

  6. Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)

    Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline.

    The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications.

    Measured: Baseline to End of Treatment (up to 81 months)

  7. Change in Karnofsky Performance Status

    The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classified participants according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.

    Measured: Baseline to End of Treatment (up to 81 months)

  8. Changes in Plasma Concentrations of Disease-Associated Chemokines and Cytokines

    Analysis of the cytokine/chemokine was planned to be performed on a subset of samples from this study along with a subset of samples from other studies. Therefore, data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

    Measured: Enrollment to End of Treatment (up to 81 months)

  9. Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms

    This composite endpoint measured the safety and tolerability profile of idelalisib. "Clinically meaningful" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.

    Measured: Start of Treatment to End of Treatment (up to 81 months) plus 30 days

  10. Study Drug Exposure

    The average idelalisib exposure was summarized.

    Measured: Start of Treatment to End of Treatment (up to 81 months)

  11. Idelalisib Plasma Concentration

    Measured: Predose and at 1.5 hours (± 5 minutes) postdose on Day 29

  12. PK Parameter: Cmax

    Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.

    Measured: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29

  13. PK Parameter: Tmax

    Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).

    Measured: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29

  14. PK Parameter: AUClast

    AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration

    Measured: Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2011 (estimated)
  2. Study start18 Mar 2011
  3. Primary completion2 May 2018
  4. Study completion16 May 2018

Resources

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
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01282424
Sponsor's protocol ID
101-09
Other IDs
2010-022155-33
Acronym
DELTA
Status last verified
Jun 2019
First submitted
21 Jan 2011
Last updated
11 Jul 2019
Data monitoring committee
No
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.

Publications

  • Salles GA, Kahl, BS, Wagner-Johnston ND, et al. Interim results from a phase 2 study of PI3Kδ inhibitor idelalisib in patients with relapsed indolent non-Hodgki lymphoma (iNHL) refractory to both rituximab and an alkylating agent. 12th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, June 19-22, 2013 Abstract No: 064bis.

  • Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kdelta inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014 Mar 13;370(11):1008-18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22.

    PubMed 24450858

  • Ma S, Chan RJ, Gu L, Xing G, Rajakumaraswamy N, Ruzicka BB, Wagner-Johnston ND. Retrospective Analysis of the Impact of Adverse Event-Triggered Idelalisib Interruption and Dose Reduction on Clinical Outcomes in Patients With Relapsed/Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 May;21(5):e432-e448. doi: 10.1016/j.clml.2020.12.016. Epub 2020 Dec 24.

    PubMed 33516721

  • Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.

    PubMed 33297794

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Idelalisib in people with Follicular Lymphoma and Small Lymphocytic Lymphoma, run by Gilead Sciences at 41 sites in 6 countries.

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 13 inclusion and 14 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, United Kingdom, France, Germany, Italy and 1 more country. 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 4 Sep 2014). 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 (time frame: Start of Treatment to End of Treatment (up to 81 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01282424, which also lists 4 linked publications.

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 11 Jul 2019.

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