Completed

NCT Number: NCT01744691

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adelaide, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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:

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

Treatment and study plan

Ibrutinib

Drug

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

Primary outcomes

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.

Secondary outcomes

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

Number of participants who had experienced at least one treatment emergent AE

Sponsors and collaborators

Lead sponsor

Pharmacyclics LLC.

Industry

Collaborators

Janssen Research & Development, LLC

Registry information

Official study 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)

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2016
First posted: Dec 7, 2012
Registry last updated: Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.