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
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Ann Arbor, MI
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Atlanta, GA
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Chicago, IL
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Columbus, OH
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Duarte, CA
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Goldsboro, North Carolina 27534
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Goldsboro, NC
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Houston, TX
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Kogarah,
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La Jolla, CA
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Laredo, TX
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Las Vegas, NV
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Louisville, KY
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New Hyde Park, NY
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Pittsburgh, PA
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Portland, OR
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Rochester, NY
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Saint Louis, MO
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San Antonio, TX
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Santa Rosa, CA
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Seattle, WA
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Stanford, CA
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Walla Walla, WA
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Worcester, MA
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