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

Completed · Phase 1/Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT02401048

Run by

Pharmacyclics LLC.

People needed

61

Starts

2015-05-01

Expected to finish

2017-11-01

Last updated by the study team

2019-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Absolute Neutrophil Count >1500 cells/mm3
• Platelets >50000 cells/mm3
• Hemoglobin >8.0 g/dL
• Adequate hepatic and renal function:
• AST or ALT ≤2.5 x ULN
• Bilirubin ≤1.5 x ULN
• Estimated creatinine clearance (Cockcroft-Gault) >40 mL/min
• ECOG 0 or 1

You may not qualify if…

• 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

Where it is running

• Site-0397 — Birmingham, Alabama, United States
• Site-0047 — Duarte, California, United States
• Site-0038 — Stanford, California, United States
• Site-0388 — Miami, Florida, United States
• Site-0126 — Chicago, Illinois, United States
• Site-0020/0173 — Boston, Massachusetts, United States
• Site-0729 — Ann Arbor, Michigan, United States
• Site-0130 — Detroit, Michigan, United States
• Site-0343 — Hackensack, New Jersey, United States
• Site-0402 — Philadelphia, Pennsylvania, United States
• Site-0114 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.