Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:65 - Any
Updated:10/13/2018
Start Date:August 28, 2012
End Date:April 30, 2023

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An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia
(CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib
versus Chlorambucil)


Inclusion Criteria:

1. Randomized in the parent study, PCYC-1115-CA

2. Informed consent for Study PCYC-1116-CA

3. IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study

Exclusion Criteria:

1. Disease progression involving the central nervous system (CNS) or transformation to
another histology

2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to
treat CLL if administered before date of IRC confirmed progressive disease

3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an
investigational drug

4. Requirement for treatment with a strong CYP3A inhibitor

5. Uncontrolled systemic infection or requirement for IV antibiotics

6. Noncompliance on the parent study(PCYC-1115-CA)
We found this trial at
23
sites
6
mi
from 43215
Columbus, OH
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164
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from 43215
Ann Arbor, MI
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436
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from 43215
Atlanta, GA
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274
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from 43215
Chicago, IL
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1955
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from 43215
Duarte, CA
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Goldsboro, North Carolina 27534
422
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from 43215
Goldsboro, NC
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991
mi
from 43215
Houston, TX
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9463
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from 43215
Kogarah,
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1926
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from 43215
La Jolla, CA
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1275
mi
from 43215
Laredo, TX
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1767
mi
from 43215
Las Vegas, NV
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188
mi
from 43215
Louisville, KY
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494
mi
from 43215
New Hyde Park, NY
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162
mi
from 43215
Pittsburgh, PA
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2026
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from 43215
Portland, OR
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355
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from 43215
Rochester, NY
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394
mi
from 43215
Saint Louis, MO
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1144
mi
from 43215
San Antonio, TX
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2107
mi
from 43215
Santa Rosa, CA
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2005
mi
from 43215
Seattle, WA
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2100
mi
from 43215
Stanford, CA
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1804
mi
from 43215
Walla Walla, WA
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604
mi
from 43215
Worcester, MA
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