A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/7/2017
Start Date:May 2015
End Date:July 2018

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A Multi-Center Open-Label Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With MEDI4736, in Subjects With Relapsed or Refractory Lymphomas

The purpose of this study is to evaluate the efficacy, safety and tolerability of the
combination treatment of ibrutinib and MEDI4736 in patients with relapsed or refractory
lymphomas.


Inclusion Criteria:

- Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
or follicular lymphoma (FL)

- Measurable disease sites on CT scan (>1.5 cm in longest dimension)

- Adequate hematologic function:

1. Absolute Neutrophil Count >1500 cells/mm3

2. Platelets >50000 cells/mm3

3. Hemoglobin >8.0 g/dL

- Adequate hepatic and renal function:

1. AST or ALT ≤2.5 x ULN

2. Bilirubin ≤1.5 x ULN

3. Estimated creatinine clearance (Cockcroft-Gault) >40 mL/min

- ECOG 0 or 1

Exclusion Criteria:

- Received prior therapies: ibrutinib, or other BTK inhibitor and/or anti-PD1,
anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody

- Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor

- Primary CNS lymphoma or evidence of CNS involvement by lymphoma
We found this trial at
11
sites
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Ann Arbor, MI
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Birmingham, AL
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Hackensack, NJ
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Philadelphia, PA
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Seattle, WA
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Stanford, CA
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