Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer
| Registry | NCT04666025 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 26 (Actual) |
| Sponsor | City of Hope Medical Center (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | 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 |
| Interventions | Biospecimen Collection, Diagnostic Laboratory Biomarker Analysis, Electronic Health Record Review, Questionnaire Administration (Procedure, other) |
| Dates | start 2020-09-23, primary completion 2023-05-05, completion 2023-05-05, first posted 2020-12-14, last updated 2024-04-08 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Accelerated Phase CML, BCR-ABL1 Positive All trials for Acute Lymphoblastic Leukemia All trials of Biospecimen Collection All trials of Diagnostic Laboratory Biomarker Analysis
This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Observational (biospecimen collection, medical chart review) | Procedure: Biospecimen Collection; Other: Diagnostic Laboratory Biomarker Analysis; Other: Electronic Health Record Review; Other: Questionnaire Administration | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * ALL COHORTS: Documented written informed consent of the participant * ALL COHORTS: Recipients must have a planned allogeneic HCT procedure. MRD, MUD, and haplo HCT allowed. Usage of post-transplant cyclophosphamide (PTCy) permitted only in haplo setting * 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. Persistent lymphadenopathy on computed tomography \[CT\] or CT/positron emission tomography \[PET\] scan without progression is allowed) * 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 * ADDITIONAL CRITERIA FOR RECIPIENTS IN THE REFERENCE COHORT: Active COVID-19 infection during HCT
| Facility | City | Country | Status |
|---|---|---|---|
| City of Hope Medical Center | Duarte, California | United States |
NIH grants: P30CA033572