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Chronic Lymphocytic LeukemiaPhase 1/2NCT01090414

An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

A Phase 1/2 study testing Idelalisib in people with Chronic Lymphocytic Leukemia and Lymphoma, Non-Hodgkin, run by Gilead Sciences at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. 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
202 participants
Where
18 sitesUnited States
Study dates
22 Mar 2010to 18 Jun 2018
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

  • Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
  • Women of childbearing potential must have a negative pregnancy test to be eligible
  • Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol

Who cannot join

  • Patients who are unwilling or unable to comply with the protocol are not eligible
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Center for Cancer & Blood Disorders, PC

    Bethesda, Maryland, 20817

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • MD Anderson Cancer and Research Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • UCLA

    Los Angeles, California, 90095-1678

  • University of Wisconsin

    Madison, Wisconsin, 53792-5156

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Long Island Jewish medical Center

    New Hyde Park, New York, 11042

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Weill Medical College of Cornell

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Stanford Cancer Center

    Palo Alto, California, 94304-5548

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, 97477

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Yakima Regional Cancer Care

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies

This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.

Being tested
Idelalisib
Keywords
Idelalisib, Chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL), Phosphatidylinositol 3-kinase (PI3K)
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, 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 Zydelig®, GS-1101, CAL-101

    Idelalisib tablets or capsules administered orally

Study groups in NCT01090414
Study groupRoleWhat they receive
IdelalisibExperimentalParticipants will receive up to 350 mg of idelalisib twice daily until disease progression or 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 defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).

    Measured: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

  2. Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events

    Measured: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days

Secondary outcomes (4)

  1. Duration of Response

    Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.

    Measured: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

  2. Progression-Free Survival

    Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates.

    Measured: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

  3. Overall Survival

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

    Measured: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

  4. Time to Response

    Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response.

    Measured: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Timeline

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

  1. First posted22 Mar 2010 (estimated)
  2. Study start22 Mar 2010
  3. Primary completion18 Jun 2018
  4. Study completion18 Jun 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01090414
Sponsor's protocol ID
101-99
Status last verified
Aug 2019
First submitted
17 Mar 2010
Last updated
28 Aug 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

  • Barrientos J, Coutre SE, et al. (2014). Long-Term Follow-Up of a Phase 1 Trial of Idelalisib (ZYDELIG®) in Combination with Bendamustine, Bendamustine/Rituximab, Fludarabine, Chlorambucil, or Chlorambucil/Rituximab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) [Abstract 3343]. 56th American Society of Hematology (ASH) Annual Meeting and Exposition, San Francisco, California.

  • Barrientos JC, Leonard JP, et al. (2013). Update on a Phase 1 Study of the Selective PI3Kδ Inhibitor, Idelalisib (GS-1101) in Combination with Rituximab and/or Bendamustine in Patients with Relapsed or Refractory CLL [Presentation]. American Society for Clinical Oncology (ASCO) Annual Meeting, Chicago, Illinois.

  • Barrientos JC, Wagner-Johnston ND, et al. (2013). Chemo-Immunotherapy Combination of Idelalisib with Bendamustine/Rituximab or Chlorambucil/Rituximab in Patients with Relapsed/ Refractory CLL Demonstrates Efficacy and Tolerability [Poster 4176]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.

  • Barrientos JC, Sharman J, et al. (2012). GS-1101 (CAL-101), A Selective Phosphatidylinositol 3-Kinase-Delta Inhibitor, in Combination With Ofatumumab for the Treatment of Relapsed/ Refractory CLL [Abstract 1062]. Haematologica: the Hematology Journal 17th Congress of the European Hematology Association 14-17 June 2012 Amsterdam; Netherlands 97 (Suppl 1): 433.

  • Benson D, Kahl BS, et al. (2013). Final Results of a Phase 1 Study of Idelalisib, a Selective Inhibitor of PI3Kδ, in Patients with Relapsed or Refractory Indolent non-Hodgkin Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

  • Brown JR, Cheson BD, et al. (2015). Patterns of Lymphocytosis in Patients with CLL or Small Lymphocytic Lymphoma (SLL) Treated with Idelalisib. 57th ASH Annual Meeting and Exposition, Orlando, Florida.

  • Brown JR, Byrd JC, Coutre SE, Benson DM, Flinn IW, Wagner-Johnston ND, Spurgeon SE, Kahl BS, Bello C, Webb HK, Johnson DM, Peterman S, Li D, Jahn TM, Lannutti BJ, Ulrich RG, Yu AS, Miller LL, Furman RR. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110delta, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014 May 29;123(22):3390-7. doi: 10.1182/blood-2013-11-535047. Epub 2014 Mar 10.

    PubMed 24615777

  • Brown JR, Furman RR, et al. (2013). Final Results of a Phase 1 Study of Idelalisib (GS-1101) a Selective Inhibitor of Phosphatidylinositol 3-Kinase p110 Delta (PI3Kδ) in Patients with Relapsed or Refractory CLL [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

  • Coutre SE, Flinn IW, de Vos S, Barrientos JC, Schreeder MT, Wagner-Johnson ND, Sharman JP, Boyd TE, Fowler N, Dreiling L, Kim Y, Mitra S, Rai K, Leonard JP, Furman RR. Idelalisib in Combination With Rituximab or Bendamustine or Both in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia. Hemasphere. 2018 Apr 25;2(3):e39. doi: 10.1097/HS9.0000000000000039. eCollection 2018 Jun.

    PubMed 31723767

  • Coutre S, Barrientos C, et al. (2015). Safety of Idelalisib in B-cell Malignancies: Integrated Analysis of Eight Clinical Trials. ASCO Annual Meeting, Chicago, Illinois.

  • Coutre S, Leonard J, et al. (2015). Idelalisib Monotherapy Results in Durable Responses in Patients with Relapsed or Refractory Waldenstrom's Macroglobulinemia. ASCO Annual Meeting, Chicago, Illinois.

  • DeVos S, Wagner-Johnston ND, et al. (2014). Durable Responses Following Treatment with the PI3K-Delta Inhibitor Idelalisib in Combination with Rituximab, Bendamustine, or Both, in Recurrent Indolent non-Hodgkin Lymphoma: Phase I/II Results [Abstract 3063]. 56th ASH Annual Meeting and Exposition, San Francisco, California.

  • DeVos S, Furman RR, et al. (2013). Idelalisib, a Selective Inhibitor of PI3Kδ, in Combination with Bendamustine, Fludarabine, or Chlorambucil in Patients with Relapsed or Refractory (R/R) CLL [Poster 2878]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.

  • Flinn IW, Kahl BS, Leonard JP, Furman RR, Brown JR, Byrd JC, Wagner-Johnston ND, Coutre SE, Benson DM, Peterman S, Cho Y, Webb HK, Johnson DM, Yu AS, Ulrich RG, Godfrey WR, Miller LL, Spurgeon SE. Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-delta, as therapy for previously treated indolent non-Hodgkin lymphoma. Blood. 2014 May 29;123(22):3406-13. doi: 10.1182/blood-2013-11-538546. Epub 2014 Mar 10.

    PubMed 24615776

  • Furman R, DeVos S, et al. (2014). Long-Term Follow-Up of a Phase 1 Study of Idelalisib (ZYDELIG®) in Combination with Anti-CD20 Antibodies (Rituximab or Ofatumumab) in Patients with Relapsed or Refractory CLL. 56th ASH Annual Meeting and Exposition, San Francisco, California.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Idelalisib in people with Chronic Lymphocytic Leukemia and Lymphoma, Non-Hodgkin, run by Gilead Sciences at 18 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 3 inclusion and 2 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 28 Aug 2019). 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: Parent study baseline to end of study 101-99 (maximum: up to 91.2 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?

On the ClinicalTrials.gov record for NCT01090414, which also lists 29 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 28 Aug 2019; AzTrials last refreshed its copy on 2 Nov 2026.

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