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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01744691|
Recruitment Status : Completed
First Posted : December 7, 2012
Results First Posted : June 9, 2015
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia With 17p Deletion Small Lymphocytic Lymphoma With 17p Deletion||Drug: Ibrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||April 2016|
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744691
|Study Director:||Alvina Chu, MD||Pharmacyclics LLC.|