SARS-CoV-2 Donor-Recipient Immunity Transfer

  • STATUS
    Recruiting
  • End date
    Sep 23, 2022
  • participants needed
    36
  • sponsor
    City of Hope Medical Center
Updated on 2 September 2021
remission
myeloid leukemia
cyclophosphamide
chronic lymphocytic leukemia
lymphoma
myelofibrosis
granulocyte colony stimulating factor
leukemia
g-csf
mobilized
lymphadenopathy

Summary

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.

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.

Details
Condition Hematologic Malignancy, Chronic Phase CML, BCR-ABL1 Positive, Lymphocytic Leukemia, Chronic, Preleukemia, myelodysplastic syndrome (mds), acute lymphoblastic leukemia, acute lymphoid leukaemia, Bone Marrow Disorder, leukemia chronic lymphocytic, Acute myeloid leukemia, Hodgkin's Disease, Acute Myelogenous Leukemia (AML), hodgkin's lymphoma, Covid 19 Infection, leukemia, acute lymphoblastic, acute lymphocytic leukemia, hematopoietic and lymphoid cell neoplasm, childhood ALL, hodgkin's lymphomas, acute myeloblastic leukemia, hodgkin, acute lymphoblastic leukemia (all), non-hodgkin's lymphoma (nhl), Blood Cancer, Hematologic Neoplasms, myelodysplastic syndromes, Non-Hodgkin's Lymphoma, hodgkins lymphoma, Lymphocytic Leukemia, Acute, small lymphocytic lymphoma, Post-essential Thrombocythemia Myelofibrosis, anll, chronic lymphocytic leukemia (cll), Myelodysplastic Syndromes (MDS), MYELOPROLIFERATIVE DISORDER, Chronic Lymphocytic Leukemia, Bone marrow disorder, lymphoblastic lymphoma, Myelosclerosis with myeloid metaplasia, myeloproliferative neoplasm, myeloproliferative disorders, hodgkin lymphomas, Myelofibrosis, acute myelogenous leukemia, Accelerated Phase CML, BCR-ABL1 Positive, MYELODYSPLASTIC SYNDROME, Acute Myeloid Leukemia, Hematologic Cancer, Lymphoma, Myeloproliferative Neoplasms, hematopoietic malignancy
Treatment questionnaire administration, diagnostic laboratory biomarker analysis, biospecimen collection, Electronic Health Record Review
Clinical Study IdentifierNCT04666025
SponsorCity of Hope Medical Center
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
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