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
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| ClinicalTrials.gov Identifier: NCT01744691 |
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Recruitment Status :
Completed
First Posted : December 7, 2012
Results First Posted : June 9, 2015
Last Update Posted : February 27, 2017
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Sponsor:
Pharmacyclics LLC.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia With 17p Deletion Small Lymphocytic Lymphoma With 17p Deletion | Drug: Ibrutinib | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 145 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Ibrutinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: ibrutinib
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
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Drug: Ibrutinib
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily. |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Locations
Show 55 study locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
| Study Director: | Alvina Chu, MD | Pharmacyclics LLC. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pharmacyclics LLC. |
| ClinicalTrials.gov Identifier: | NCT01744691 |
| Other Study ID Numbers: |
PCYC-1117-CA 2012-004476-19 ( EudraCT Number ) |
| First Posted: | December 7, 2012 Key Record Dates |
| Results First Posted: | June 9, 2015 |
| Last Update Posted: | February 27, 2017 |
| Last Verified: | January 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Pharmacyclics LLC.:
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CLL SLL |
Additional relevant MeSH terms:
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Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Hematologic Diseases Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes Ibrutinib Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |