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

Chronic Lymphocytic Leukemia With 17p Deletion Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01744691
• Other study ID #: PCYC-1117-CA
• Secondary ID: 2012-004476-19
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 3, 2012
• Last updated: August 25, 2015
• Start date: January 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2015
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesNew Zealand: Ministry of HealthTurkey: Clinical Drug Research Department (Klinik Ilaç Arsatirmalari Sube Mudurlugu) (MHDP)Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: March 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia With 17p Deletion
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma With 17p Deletion

Intervention

Drug:
• PCI-32765
All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pharmacyclics	Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  New Zealand,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	The primary objective of this study is to evaluate the efficacy of PCI-32765 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 11.5 (range 0.5 - 16.6) months	No
Secondary	Number of Participants With Treatment Emergent Adverse Events (AEs)	Number of participants who had experienced at least one treatment emergent AE	From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure	Yes

External Links

•   www.pharmacyclics.com