CompletedNot Applicable

SARS-CoV-2 Donor-Recipient Immunity Transfer

United States26 participantsStarted 2020-09-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 CO…

What they're measuring

Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels

Timeframe: Up to 180 days post-hematopoietic stem cell transplant (HCT)

SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels

Timeframe: Up to 180 days post-HCT

SARS-CoV-2 neutralizing antibodies

Timeframe: Up to 180 days post-HCT

Trial details

NCT IDNCT04666025

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-05-05

View on ClinicalTrials.gov More Accelerated Phase CML, BCR-ABL1 Positive trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels

Timeframe: Up to 180 days post-hematopoietic stem cell transplant (HCT)

SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels

Timeframe: Up to 180 days post-HCT

SARS-CoV-2 neutralizing antibodies

Timeframe: Up to 180 days post-HCT