Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

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 Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Acalabrutinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

  • Los Angeles California 90095 United States
  • Houston Texas 77303 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acerta Pharma BV
ID
NCT02112526
Phase
Phase 1
Study Type
Interventional
Last Updated