Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Completed · Phase 2

Conditions studied: Diffuse Large Cell B-lymphoma

In brief

The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).

Key facts

Study ID: NCT01325701
Run by: Pharmacyclics LLC.
People needed: 78
Starts: 2011-05-01
Expected to finish: 2014-10-01
Last updated by the study team: 2017-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women ≥ 18 years of age.
ECOG performance status ≤ 2.
Pathologically confirmed de novo DLBCL
Subjects must have available tissue for central pathology review to be eligible. Treatment Group 2: Subjects will be eligible if they have the non-GCB phenotype, as confirmed by Central IHC testing by the Hans method.
Relapsed or refractory disease, defined as either: 1) recurrence of disease after a CR, or 2) PR, SD, or progressive disease (PD) at completion of the treatment regimen preceding entry to the study (residual disease): Subjects must have previously received an appropriate first-line treatment regimen. Subjects who have not received HDT/ASCT must be ineligible for HDT/ASCT
Treatment Group 1: Subjects must have ≥ 1 measurable (> 2 cm in longest dimension) disease sites on CT scan. Treatment Group 2: Subjects must have ≥ 1 measurable (> 1.5 cm in longest dimension) disease sites on CT scan.

You may not qualify if…

Transformed DLBCL or DLBCL with coexistent histologies (eg, FL or MALT).
Primary mediastinal (thymic) large B-cell lymphoma.
Known central nervous system lymphoma. In addition, for subjects in Treatment Group 2, known leptomeningeal involvement is exclusionary.
Certain exclusions on prior therapy
Major surgery within 2 weeks of first dose of study drug.
Any of the following laboratory abnormalities:
ANC < 0.75 x 10\^9/L. Treatment Group 2: Eligible subjects must be independent of growth factor support for 7 days prior to the screening lab tests.
Platelet count < 50 x 10\^9/L independent of transfusion support. Treatment Group 2 only: Eligible subjects must be independent of transfusion support for 7 days prior to the screening lab tests.
AST or ALT ≥ 3.0 x upper limit of normal (ULN)
Creatinine > 2.0 x ULN
Treatment Group 2 only: Hemoglobin < 8.0 g/dL
Treatment Group 2 only: Total Bilirubin > 1.5 x ULN
Requires or has received anticoagulation treatment with warfarin or equivalent Vitamin K antagonists (eg, phenprocoumon)
Treatment Group 2: Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor
Treatment Group 2: Known bleeding diathesis, eg, von Willebrand's disease, hemophilia.

Where it is running

UCLA Medical Center — Los Angeles, California, United States
Stanford University School of Medicine — Stanford, California, United States
National Cancer Institute — Bethesda, Maryland, United States
Mayo Clinic — Rochester, Minnesota, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Long Island Jewish Medical Center — New Hyde Park, New York, United States
New York University — New York, New York, United States
Weill Medical College of Cornell University — New York, New York, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
University of Rochester School of Medicine and Dentistry — Rochester, New York, United States
The Ohio Sate university — Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Univerity of Washington — Seattle, Washington, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.