A Multicenter Phase 2 Study of PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
This study is currently recruiting participants.
Verified May 2013 by Pharmacyclics
Sponsor:
Pharmacyclics
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01744691
First received: December 3, 2012
Last updated: June 11, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia With 17p Deletion Small Lymphocytic Lymphoma With 17p Deletion |
Drug: PCI-32765 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Pharmacyclics:
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: 6 -12 months after last patient enrolled ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of Response [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: No ]
- Safety Parameters: Number and type of adverse events [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- Progression-free survival [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 111 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PCI-32765
All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
|
Drug: PCI-32765
All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
|
Detailed Description:
This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of PCI-32765 in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive PCI-32765 until disease progression or unacceptable toxicity occurs.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 PCI-32765
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744691
Contacts
| Contact: Michelle Stevens-Brogan | 855-427-8846 | pharmacyclics@medcomsol.com |
Locations
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jeanne Lichty 713-794-4683 JMLichty@mdanderson.org | |
Sponsors and Collaborators
Pharmacyclics
Investigators
| Study Director: | Alvina Chu, MD | Pharmacyclics |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01744691 History of Changes |
| Other Study ID Numbers: | PCYC-1117, 2012-004476-19 |
| Study First Received: | December 3, 2012 |
| Last Updated: | June 11, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices New Zealand: Ministry of Health Turkey: Clinical Drug Research Department (Klinik Ilaç Arsatirmalari Sube Mudurlugu) (MHDP) Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Pharmacyclics:
|
CLL SLL |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013