SARS-CoV-2 Donor-Recipient Immunity Transfer

Acute Myeloid Leukemia Clinical Trial

Official title: Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Accelerated Phase CML, BCR-ABL1 Positive
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Phase CML, BCR-ABL1 Positive
• COVID-19
• COVID-19 Infection
• Hematopoietic and Lymphoid Cell Neoplasm
• Hodgkin Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoblastic Lymphoma
• Lymphoma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myelofibrosis
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Non-Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT04666025
• Study type: Observational
• Source: City of Hope Medical Center
• Status: Completed
• Start date: September 23, 2020
• Completion date: May 5, 2023