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OpenTrials
Completed

NCT Number: NCT02112526

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

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).

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Key information

Conditions

Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Leicester, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Acalabrutinib

Drug

Other names: ACP-196

Primary outcomes

  1. Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.

    Time frame: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.

    Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.

Secondary outcomes

  1. Area Under the Plasma Concentration (AUC)

    Time frame: 1 Cycle (28 days)

    To Characterize the Pharmacokinetic parameter AUC of acalabrutinib

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 1 Cycle (28 days)

    To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib

  3. Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)

    Time frame: 2 Cycles (1 cycle = 28 days) and at end of treatment

    To evaluate the concentration pharmacodynamic effects of acalabrutinib

  4. Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)

    Time frame: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)

    To evaluate the activity of acalabrutinib as measured by ORR

Sponsors and collaborators

Lead sponsor

Acerta Pharma BV

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2020
Study completion
2024
First posted
Apr 14, 2014
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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