CompletedNot applicableNCT04666025
Official study title

SARS-CoV-2 Donor-Recipient Immunity Transfer

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBiospecimen Collection and Diagnostic Laboratory Biomarker Analysis

Plus 2 other study approaches.

Who it may be forAccelerated Phase CML, BCR-ABL1 Positive · Acute Lymphoblastic Leukemia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 8, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?City of Hope Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
City of Hope Medical Center
Interventions being studied
Procedure: Biospecimen Collection; Other: Diagnostic Laboratory Biomarker Analysis; Other: Electronic Health Record Review; Other: Questionnaire Administration
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Medical CenterDuarte, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 8, 2024. Always confirm current availability with the study team.

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