Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - ALL COHORTS: Documented written informed consent of the participant.
- - ALL COHORTS: Recipients must have a planned allogeneic HCT procedure.
- - ALL COHORTS: GCSF-mobilized peripheral blood stem cell (PBSC) only as graft source.
- - ALL COHORTS: Planned HCT with minimal to no-T cell depletion of graft for the treatment of the following hematologic malignancies: - Lymphoma (Hodgkin and non-Hodgkin) - Myelodysplastic syndrome.
- - Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood.
- - Acute myeloid leukemia in first or second remission.
- - Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.
- - Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis.
- - ALL COHORTS: Willingness to.
- - Provide blood samples and saliva specimens.
- - Permit medical record review.
- - ADDITIONAL CRITERIA FOR RECIPIENTS IN THE MAIN COHORT: - Absence of documented COVID-19 history and active COVID-19 infection.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|City of Hope Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Monzr M Al Malki|
|Principal Investigator Affiliation||City of Hope Comprehensive Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Accelerated Phase CML, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Chronic Phase CML, BCR-ABL1 Positive, COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma|
- I. To establish the possibility of anti-SARS-CoV-2 adaptive immunity transfer from matched related (MRD) or unrelated (MUD) HCT donor to HCT recipient.
- I. To explore anti-SARS-CoV-2 adaptive immunity transfer in the haploidentical (haplo) HCT setting.
- II. To assess the prevalence and change over time of SARS-CoV-2 seropositive donors among all consented donors.
: Observational (biospecimen collection, medical chart review)
DONORS: Prior to HCT, sibling donors (MRD and haplo) undergo a nasopharyngeal swab per standard of care for SARS-Cov-2 testing. For MUD donors, initial testing may consist of a questionnaire. All donors undergo collection of blood and saliva at the time of granulocyte-colony stimulating factor (G-CSF). Donors' medical charts are also reviewed. RECIPIENTS: Patients undergo a nasopharyngeal swab for SARS-Cov-2 testing at 30, 60, 90, 120 days post-HCT, and afterwards as deemed necessary by the treating physician. Patients also undergo the collection of blood and saliva specimens at days 30, 60, 90, 120, 150, and 180 post-HCT. Recipients' medical charts are also reviewed.
Procedure: - Biospecimen Collection
Undergo collection of nasopharyngeal swabs, blood, and saliva samples
Other: - Diagnostic Laboratory Biomarker Analysis
Other: - Electronic Health Record Review
Medical charts are reviewed
Other: - Questionnaire Administration
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.