Trial Search Results

A Multi-Center Study of 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 subjects with relapsed or refractory lymphomas.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pharmacyclics LLC.

Collaborator: Janssen Research & Development, LLC

Intervention(s):

  • Drug: Ibrutinib
  • Drug: MEDI4736

Phase:

Phase 1/Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ami Okada
650-725-4968
Not Recruiting