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

Trial ID or NCT#

NCT02401048

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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. 1. Absolute Neutrophil Count \>1500 cells/mm3 2. Platelets \>50000 cells/mm3 3. Hemoglobin \>8.0 g/dL* Adequate hepatic and renal function:
    2. 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:
  1. * 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
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Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology
Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD
Medical oncologist, Lymphoma specialist, Cancer geneticist
Moghadam Family Professor
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology
Michael Khodadoust
Michael Khodadoust
Lymphoma specialist, Cutaneous oncology specialist, Hematologist, Hematologist-Oncologist
Assistant Professor of Medicine (Oncology) and of Dermatology
Neel K. Gupta
Neel K. Gupta
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology

Contact us to find out if this trial is right for you.

Contact

Ami Okada
650-725-4968

View on ClinicalTrials.gov