SARS-CoV-2 Donor-Recipient Immunity Transfer
Purpose
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.
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04666025
- Status
- Completed
- Sponsor
- City of Hope Medical Center
Detailed Description
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.