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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01744691
First received: December 3, 2012
Last updated: May 21, 2015
Last verified: May 2015
  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: The median time on study for all treated participants is 11.5 (range 0.5 - 16.6) months ] [ Designated as safety issue: No ]
    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.


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 ] [ Designated as safety issue: Yes ]
    Number of participants who had experienced at least one treatment emergent AE


Enrollment: 145
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744691

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pharmacyclics
Janssen Research & Development, LLC
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-CA, 2012-004476-19
Study First Received: December 3, 2012
Results First Received: May 21, 2015
Last Updated: May 21, 2015
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
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 31, 2015