NCT01744691

Brief 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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

Geographic Reach
9 countries

55 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 9, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 27, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

December 3, 2012

Results QC Date

May 21, 2015

Last Update Submit

January 9, 2017

Conditions

Chronic Lymphocytic Leukemia With 17p DeletionSmall Lymphocytic Lymphoma With 17p Deletion

Keywords

CLLSLL

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure

Study Arms (1)

ibrutinib

EXPERIMENTAL

All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.

Drug: Ibrutinib

Interventions

IbrutinibDRUG

All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

ibrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (55)

Unknown Facility

Phoenix, Arizona, United States

Location

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Duarte, California, United States

Location

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Greenbrae, California, United States

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La Jolla, California, United States

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Stanford, California, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, United States

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Hackensack, New Jersey, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Goldsboro, North Carolina, United States

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Columbus, Ohio, United States

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Toldedo, Ohio, United States

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Houston, Texas, United States

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Adelaide, Australia

Location

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Coburg, Australia

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East Melbourne, Australia

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Fremantle, Australia

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Antwerp, Belgium

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Bruges, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Kortrijk, Belgium

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Leuven, Belgium

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Roeselare, Belgium

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Edmonton, Alberta, Canada

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Cologne, Germany

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Dresden, Germany

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Heidelberg, Germany

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Munich, Germany

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Ulm, Germany

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Auckland, New Zealand

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Christchurch, New Zealand

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Gothenburg, Sweden

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Lund, Sweden

Location

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Stockholm, Sweden

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Ankara, Turkey (Türkiye)

Location

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Gaziantep, Turkey (Türkiye)

Location

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Istanbul, Turkey (Türkiye)

Location

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Izmir, Turkey (Türkiye)

Location

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Kayseri, Turkey (Türkiye)

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Bournemouth, United Kingdom

Location

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Glasgow, United Kingdom

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Leeds, United Kingdom

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Leicester, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Newcastle upon Tyne, United Kingdom

Location

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Oxford, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27637985DERIVED

Related Links

MeSH Terms

Interventions

ibrutinib

Results Point of Contact

Title
Dr. Alvina Chu
Organization
Pharmacyclics, Inc.
medinfo@pcyc.com
855-427-8846

Study Officials

  • Alvina Chu, MD

    Pharmacyclics LLC.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 7, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

April 1, 2016

Last Updated

February 27, 2017

Results First Posted

June 9, 2015

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)NZ(2)US(18)AU(4)SE(3)GB(10)BE(7)CA(1)TU(5)