Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers

PRIMARY OBJECTIVES; I. Identify changes in immune system parameters in patients receiving
immunotherapies (including immune checkpoint inhibitors, immunostimulatory/immunomodulatory
agents, cellular therapies, stem cell transplantation) and compare to changes in patients
receiving conventional chemotherapy, targeted-agent therapy, and healthy normal volunteers
using multiparameter flow cytometry, time-of-flight mass cytometry, cytokine quantification,
functional analysis of immune cell subsets isolated via fluorescence activated cell sorting
(FACS), and genetic and proteomic techniques (deoxyribonucleic acid [DNA] sequencing,
ribonucleic acid sequence [RNASeq], reverse transcriptase-polymerase chain reaction [RT-PCR],
Western blot).

SECONDARY OBJECTIVES:

I. Optimize methods for measuring functional status of circulating immune cells and
hematopoietic progenitors (activation, inhibition, cytotoxicity, proliferative capacity).

II. Use genetic and epigenetic techniques to a) study clonal diversity in T cell subsets b)
determine the genetic basis for T cell immune reconstitution following stem cell
transplantation.

OUTLINE:

Patients and healthy normal volunteers undergo collection of peripheral blood samples for
analysis via flow cytometry, RNASeq, immunohistochemistry, cytometry by time of flight
(CyTOF) experiments, cell cultures, and functional studies of immune cell subsets obtained by
FACS. Patients also undergo collection of bone marrow and leukopheresis/leukoreduction
specimens, and single cell suspensions and bulk excised tumor biopsies are obtained from
routine testing for analysis via immunohistochemistry or CyTOF.

After completion of study, patients are followed up for up to 2 years.

Inclusion Criteria:

- All patients known to have cancer, an immune-mediated hematologic diagnosis, or a
healthy normal volunteer

- Definition of immune-mediated hematologic diagnosis: diagnoses for which immune
dysfunction and/or immune system directed therapy (eg. aplastic anemia, autoimmune
hemolytic anemia, immune thrombocytopenic purpura [ITP], etc.) are involved

- Definition of healthy normal volunteer: persons lacking diagnoses of any type of
cancer, diabetes, cardiovascular diseases, non-hematologic autoimmune disease (eg.
systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], Crohn's disease) and
not taking any immunosuppressive medications

- Patients must have been seen in the Norris Hospital and outpatient clinics, or the Los
Angeles County (LAC)-University of Southern California (USC) Medical Center or
outpatient clinics; healthy volunteers can be recruited without any physician visit
appointments since their labs are strictly for clinical research and not for personal
health issues unrelated to the project

Exclusion Criteria:

- Unable to give informed consent to specimen collection

- Known human immunodeficiency virus (HIV) positive status

- Persons taking any type of immunosuppressive medication are excluded from
participating as healthy normal volunteers

- Any patient for whom specimen collection is judged to be unsafe (for example, for
patients unable to establish venous access)