Status:
COMPLETED
SARS-CoV-2 Donor-Recipient Immunity Transfer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase CML, BCR-ABL1 Positive
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Brief 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. S...
Detailed 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. T...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04666025
Start Date
September 23 2020
End Date
May 5 2023
Last Update
April 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope Medical Center
Duarte, California, United States, 91010