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A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
Not Recruiting
Trial ID: NCT02401048
Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in subjects with relapsed or refractory lymphomas.
Official Title
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
Stanford Investigator(s)
Michael Khodadoust
Assistant Professor of Medicine (Oncology) and of Dermatology
Neel K. Gupta
Clinical Associate Professor, Medicine - Oncology
Ash A. Alizadeh, MD/PhD
Moghadam Family Professor
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Eligibility
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
Intervention(s):
drug: Ibrutinib
drug: MEDI4736
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ami Okada
650-725-4968