SARS-CoV-2 Donor-Recipient Immunity Transfer

City of Hope

Status: Completed

Conditions: Myelofibrosis; Hodgkin Lymphoma; Chronic Phase CML, BCR-ABL1 Positive; COVID-19 Infection; Non-Hodgkin Lymphoma; Hematopoietic and Lymphoid Cell Neoplasm; Accelerated Phase CML, BCR-ABL1 Positive; Myeloproliferative Neoplasm; Lymphoblastic Lymphoma; Chronic Lymphocytic Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia

Treatments: Other: Diagnostic Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04666025

NCI-2020-11156 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

20153 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

26 participants in 1 patient group

Observational (biospecimen collection, medical chart review)

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Other: Electronic Health Record Review

Other: Questionnaire Administration

Other: Diagnostic Laboratory Biomarker Analysis