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ACP-196, a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV
ClinicalTrials.gov Identifier:
NCT02112526
First received: April 10, 2014
Last updated: February 24, 2016
Last verified: November 2015
  Purpose
To characterize the safety profile of ACP-196 in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).

Condition Intervention Phase
Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL) Drug: ACP-196 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Acerta Pharma BV:

Primary Outcome Measures:
  • To characterize the safety profile of ACP-196 in subjects with relapsed or refractory ABC DLBCL [ Time Frame: 1 Cycle (28 days) ]

Estimated Enrollment: 20
Study Start Date: July 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACP-196
ACP-196
Drug: ACP-196

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Pathologically confirmed de novo ABC DLBCL
  • Relapsed or refractory disease
  • Subjects must have ≥ 1 measurable disease sites

Exclusion Criteria:

  • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF > 50%
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Breast feeding or pregnant
  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: NCT02112526

Locations
United States, California
Los Angeles, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Georgia
Atlanta, Georgia, United States
United States, New York
New York, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Texas
Houston, Texas, United States
United Kingdom
Leicester, United Kingdom
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Sandeep Inamdar Medical Monitor
  More Information

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02112526     History of Changes
Other Study ID Numbers: ACE-LY-002
Study First Received: April 10, 2014
Last Updated: February 24, 2016

Keywords provided by Acerta Pharma BV:
de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Novo Activated B-cell (ABC)
Novo Activated B-cell
ABC DLBCL
DLBCL
Lymphoma
B-Cell
Immunoproliferative Disorders
Immune System Diseases

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on June 23, 2017