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Br J Haematol. 2017 Feb;176(4):583-590. doi: 10.1111/bjh.14451. Epub 2017 Jan 5.

Results of a phase I-II study of fenretinide and rituximab for patients with indolent B-cell lymphoma and mantle cell lymphoma.

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Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.
Department of Radiology, Harvard Medical School, MGH Hospital, Boston, MA, USA.
Swedish Cancer Institute, Seattle, WA, USA.
Division of Hematopathology, Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.


Fenretinide, a synthetic retinoid, induces apoptotic cell death in B-cell non-Hodgkin lymphoma (B-NHL) and acts synergistically with rituximab in preclinical models. We report results from a phase I-II study of fenretinide with rituximab for B-NHLs. Eligible diagnoses included indolent B-NHL or mantle cell lymphoma. The phase I design de-escalated from fenretinide at 900 mg/m2 PO BID for days 1-5 of a 7-day cycle. The phase II portion added 375 mg/m2 IV rituximab weekly on weeks 5-9 then every 3 months. Fenretinide was continued until progression or intolerance. Thirty-two patients were treated: 7 in phase I, and 25 in phase II of the trial. No dose-limiting toxicities were observed. The phase II component utilized fenretinide 900 mg/m2 twice daily with rituximab. The most common treatment-related adverse events of grade 3 or higher were rash (n = 3) and neutropenia (n = 3). Responses were seen in 6 (24%) patients on the phase II study, with a median duration of response of 47 months (95% confidence interval, 2-56). The combination of fenretinide and rituximab was well tolerated, yielded a modest overall response rate, but with prolonged remission durations. Further study should focus on identifying the responsive subset of B-NHL.


4HPR; B cell lymphoma; fenretinide; indolent lymphoma; retinoids

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