Clinical trial NCT04666025: SARS-CoV-2 Donor-Recipient Immunity Transfer
Official title: Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accelerated Phase CML, BCR-ABL1 Positive
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Phase CML, BCR-ABL1 Positive
COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Hodgkin Lymphoma
Lymphoblastic Lymphoma
Myelodysplastic Syndrome
Myelofibrosis
Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (donors and recipients) scheduled to undergo a standard of care donor HCT procedure.

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. 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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels
timeFrame: Up to 180 days post-HCT
measure: SARS-CoV-2 neutralizing antibodies
timeFrame: Up to 180 days post-HCT
Secondary outcomes:
measure: SARS-CoV-2 IgA concentration
timeFrame: Up to 180 days post-HCT
Other outcomes:
measure: SARS-CoV-2 -specific T cell memory profile and associated function
timeFrame: Up to 180 days post-HCT
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Monzr M Al Malki
role: PRINCIPAL_INVESTIGATOR
References: