Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).

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

Keywords

Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL), de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, de Novo Activated B-cell (ABC), de Novo Activated B-cell, ABC DLBCL, DLBCL, Lymphoma, B-Cell, Immunoproliferative Disorders, Immune System Diseases, Bruton's tyrosine kinase, B-Cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Acalabrutinib

Eligibility

You can join if…

Open to people ages 18-130

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

You CAN'T join if...

  • 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 acalabrutinib, 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

Locations

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    Houston Texas 77030 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acerta Pharma BV
Links
Related Info Related Info #2
ID
NCT02112526
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 21 people participating
Last Updated