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
Michael Khodadoust

Assistant Professor of Medicine (Oncology) and of Dermatology

Neel K. Gupta
Neel K. Gupta

Clinical Assistant Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology

Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD

Moghadam Family Professor

Lauren Maeda
Lauren Maeda

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

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