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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. ;


Study Design


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
Contact
Status Active, not recruiting
Phase
Start date September 23, 2020
Completion date December 23, 2023

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