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

ArmDescriptionAssigned 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.
  • Procedure: Biospecimen Collection
    Undergo collection of nasopharyngeal swabs, blood, and saliva samples
  • Other: Diagnostic Laboratory Biomarker Analysis
    Correlative studies
  • Other: Electronic Health Record Review
    Medical charts are reviewed
  • Other: Questionnaire Administration
    Complete questionnaire

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.