This is a Phase II single-center open label trial of the combination of ATRA and pembrolizumab treatment in patients with histologically proven, relapsed or refractory Hodgkin Lymphoma or B-Non-Hodgkin-lymphoma.
≥ 18 years old at the time of informed consent
Ability to provide written informed consent and HIPAA authorization
Willingness to comply with all study procedures and be available for the duration of the trial
Have a performance status of 0 to 2 on the ECOG Performance Scale.
Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Known brain metastases and/or leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
Significant reduction in ECOG performance status between the screening/ baseline visit and within 72 hours prior to commencement of treatment as per trial protocol, as per the Investigator's assessment, defined as a reduction in ECOG score to 3 or 4.
Patients with a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) within 7 days prior to the first dose of trial treatment.
Single group
ATRA
Drug150 mg/m2 ATRA orally for 3 days surrounding each of the first four cycles (day -1, day 0, day +1)
Pembrolizumab
Drug200mg Q3W pembrolizumab
Incidence of Adverse Events
Safety will be assess by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Overall Response Rate
Complete Remission Rate
Patient derived myeloid-derived suppressor cells (MDSC)
Assessing the anti-tumor effect of the combination of pembrolizumab and ATRA on the reduction in myeloid-derived suppressor cells (MDSC) frequency and suppressive function through in vitro experiments using patient-derived MDSCs.
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Rita Assi
Lead sponsor
Indiana University
Sponsor institution
