Chronic Lymphocytic Leukemia With 17p DeletionPhase 2NCT01744691
A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
A Phase 2 study testing Ibrutinib in people with Chronic Lymphocytic Leukemia With 17p Deletion and Small Lymphocytic Lymphoma With 17p Deletion, run by Pharmacyclics LLC. at 55 sites in 9 countries.
Trial summary
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion
- What is being tested?
- Ibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 55 sitesin 9 countries
- Study dates
- Jan 2013to Apr 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
- Documentation of del (17p13.1)
- Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
- Measurable nodal disease by computed tomography (CT)
Who cannot join
- History or current evidence of Richter's transformation or prolymphocytic leukemia
- Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
- Prior exposure to ibrutinib
Trial locations and contacts
55 sites in 9 countries.
55 sites in 9 countries
United States18 sites
Study site
Ann Arbor, Michigan
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Columbus, Ohio
Study site
Duarte, California
Study site
Goldsboro, North Carolina
Study site
Greenbrae, California
Study site
Hackensack, New Jersey
Study site
Houston, Texas
Study site
La Jolla, California
Study site
New Hyde Park, New York
Study site
New York, New York
Study site
Phoenix, Arizona
Study site
Rochester, Minnesota, 55905
Study site
St Louis, Missouri
Study site
Stanford, California
Study site
Tampa, Florida
Study site
Toldedo, Ohio
United Kingdom10 sites
Study site
Bournemouth
Study site
Glasgow
Study site
Leeds
Study site
Leicester
Study site
Liverpool
Study site
London
Study site
Manchester
Study site
Newcastle upon Tyne
Study site
Oxford
Study site
Plymouth
Belgium7 sites
Study site
Antwerp
Study site
Bruges
Study site
Brussels
Study site
Ghent
Study site
Kortrijk
Study site
Leuven
Study site
Roeselare
Germany5 sites
Study site
Cologne
Study site
Dresden
Study site
Heidelberg
Study site
Munich
Study site
Ulm
Turkey (Türkiye)5 sites
Study site
Ankara
Study site
Gaziantep
Study site
Istanbul
Study site
Izmir
Study site
Kayseri
Australia4 sites
Study site
Adelaide
Study site
Coburg
Study site
East Melbourne
Study site
Fremantle
About this study
Official title: An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
Read the detailed description
This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.
- Conditions
- Chronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion
- Being tested
- Ibrutinib
- Keywords
- CLL, SLL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| ibrutinib | Experimental | All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
Measured: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
Secondary outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (AEs)
Number of participants who had experienced at least one treatment emergent AE
Measured: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionApr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia With 17p DeletionStudies of the same condition, open and under way.
- 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Alvina Chu, MD, Study director, Pharmacyclics LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744691
- Sponsor's protocol ID
- PCYC-1117-CA
- Other IDs
- 2012-004476-19
- Status last verified
- Jan 2017
- First submitted
- 3 Dec 2012
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
O'Brien S, Jones JA, Coutre SE, Mato AR, Hillmen P, Tam C, Osterborg A, Siddiqi T, Thirman MJ, Furman RR, Ilhan O, Keating MJ, Call TG, Brown JR, Stevens-Brogan M, Li Y, Clow F, James DF, Chu AD, Hallek M, Stilgenbauer S. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol. 2016 Oct;17(10):1409-1418. doi: 10.1016/S1470-2045(16)30212-1. Epub 2016 Sep 13.
PubMed 27637985
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
- ClinicalTrials.gov ID
- NCT01744691
- Acronym / sponsor ID
- PCYC-1117-CA
- Conditions
- Chronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion
- Keywords
- CLL, SLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
Detailed description
This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ibrutinib | Experimental | Drug: IbrutinibAll subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documentation of del (17p13.1)
- Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
- Measurable nodal disease by computed tomography (CT)
Key exclusion criteria (3 listed)
- History or current evidence of Richter's transformation or prolymphocytic leukemia
- Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
- Prior exposure to ibrutinib
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 |
|---|---|---|
| IbrutinibAll subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily. | Drug | ibrutinib |
Primary outcome
Overall Response Rate
Time frame: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time frame: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27637985O'Brien S, Jones JA, Coutre SE, Mato AR, Hillmen P, Tam C, Osterborg A, Siddiqi T, Thirman MJ, Furman RR, Ilhan O, Keating MJ, Call TG, Brown JR, Stevens-Brogan M, Li Y, Clow F, James DF, Chu AD, Hallek M, Stilgenbauer S. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol. 2016 Oct;17(10):1409-1418. doi: 10.1016/S1470-2045(16)30212-1. Epub 2016 Sep 13.
- www.pharmacyclics.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Lymphocytic Leukemia With 17p Deletion
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Active, not recruitingPhase 2
PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Leukemia, Leukemia, Lymphocytyc
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.
Alvina Chu, MD study director
Pharmacyclics LLC.
55 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibrutinib in people with Chronic Lymphocytic Leukemia With 17p Deletion and Small Lymphocytic Lymphoma With 17p Deletion, run by Pharmacyclics LLC. at 55 sites in 9 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 3 inclusion and 3 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, United Kingdom, Belgium, Germany, Turkey (Türkiye) and 4 more countries. 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 9 Jun 2015). 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: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) 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 NCT01744691, which also lists 1 linked publication.
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 27 Feb 2017.