Safety and Efficacy Study of Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2011
End Date:October 2014

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A Multicenter, Open-label, Phase 2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects With Relapsed or Refractory or de Novo Diffuse Large B-cell Lymphoma (DLBCL)

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


Inclusion Criteria:

1. Men and women ≥ 18 years of age.

2. ECOG performance status ≤ 2.

3. Pathologically confirmed de novo DLBCL

4. 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.

5. 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

6. 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.

Exclusion Criteria:

1. Transformed DLBCL or DLBCL with coexistent histologies (eg, FL or MALT).

2. Primary mediastinal (thymic) large B-cell lymphoma.

3. Known central nervous system lymphoma. In addition, for subjects in Treatment Group
2, known leptomeningeal involvement is exclusionary.

4. Certain exclusions on prior therapy

5. Major surgery within 2 weeks of first dose of study drug.

6. Any of the following laboratory abnormalities:

1. 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.

2. 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.

3. AST or ALT ≥ 3.0 x upper limit of normal (ULN)

4. Creatinine > 2.0 x ULN

5. Treatment Group 2 only: Hemoglobin < 8.0 g/dL

6. Treatment Group 2 only: Total Bilirubin > 1.5 x ULN

7. Requires or has received anticoagulation treatment with warfarin or equivalent
Vitamin K antagonists (eg, phenprocoumon)

8. Treatment Group 2: Requires treatment with a strong cytochrome P450 (CYP) 3A4/5
inhibitor

9. Treatment Group 2: Known bleeding diathesis, eg, von Willebrand's disease,
hemophilia.
We found this trial at
15
sites
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Bethesda, Maryland
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Columbus, Ohio 43210
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Rochester, Minnesota 55905
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Seattle, Washington 98109
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