Accelerated Phase CML, BCR-ABL1 PositiveNCT04666025
SARS-CoV-2 Donor-Recipient Immunity Transfer
An observational study of Accelerated Phase CML, BCR-ABL1 Positive and Acute Lymphoblastic Leukemia, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accelerated Phase CML, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Biospecimen Collection, Diagnostic Laboratory Biomarker Analysis and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 5 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (donors and recipients) scheduled to undergo a standard of care donor HCT procedure.
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Being tested
- Biospecimen Collection, Diagnostic Laboratory Biomarker Analysis, Electronic Health Record Review, Questionnaire Administration
- Medical subject headings
- Leukemia, Myeloid, Accelerated Phase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Chronic-Phase, COVID-19, Hematologic Neoplasms, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of nasopharyngeal swabs, blood, and saliva samples
Diagnostic Laboratory Biomarker AnalysisOther
Correlative studies
Electronic Health Record ReviewOther
Medical charts are reviewed
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection, medical chart review) | 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. Receives: Procedure: Biospecimen Collection; Other: Diagnostic Laboratory Biomarker Analysis; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S will be measured as a correlate of immunity transfer efficiency.
Measured: Up to 180 days post-hematopoietic stem cell transplant (HCT)
SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA. The qualitative assays will be developed to investigate nucleocapsid (N)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.
Measured: Up to 180 days post-HCT
SARS-CoV-2 neutralizing antibodies
Evaluation of SARS-CoV-2 neutralizing antibody titers in serum samples will be performed using SARS-CoV-2 lentiviral-pseudovirus based on published protocols. Spike incorporation into the pseudovirus will be verified and quantified by western blot using Spike-specific antibodies (Sino Biological) and by ELISA using Spike Detection kit (Sino Biological), respectively.
Measured: Up to 180 days post-HCT
Secondary outcomes (1)
SARS-CoV-2 IgA concentration
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA.
Measured: Up to 180 days post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start23 Sep 2020
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Accelerated Phase CML, BCR-ABL1 PositiveStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Monzr M Al Malki, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666025
- Sponsor's protocol ID
- 20153
- Other IDs
- NCI-2020-11156, 20153, P30CA033572
- Status last verified
- Apr 2024
- First submitted
- 10 Dec 2020
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
La Rosa C, Chiuppesi F, Park Y, Zhou Q, Yang D, Gendzekhadze K, Ly M, Li J, Kaltcheva T, Ortega Francisco S, Gutierrez MA, Ali H, Otoukesh S, Amanam I, Salhotra A, Pullarkat VA, Aldoss I, Rosenzweig M, Aribi AM, Stein AS, Marcucci G, Dadwal SS, Nakamura R, Forman SJ, Al Malki MM, Diamond DJ. Functional SARS-CoV-2-specific T cells of donor origin in allogeneic stem cell transplant recipients of a T-cell-replete infusion: A prospective observational study. Front Immunol. 2023 Mar 3;14:1114131. doi: 10.3389/fimmu.2023.1114131. eCollection 2023.
PubMed 36936918La Rosa C, Chiuppesi F, Park Y, Gendzekhadze K, Zhou Q, Faircloth K, Kaltcheva T, Johnson D, Ortega Francisco S, Amanam I, Otoukesh S, Pullarkat VA, Nakamura R, Diamond DJ, Forman SJ, Al Malki MM. Adoptive transfer of functional SARS-COV-2-specific immunity from donor graft to hematopoietic stem cell transplant recipients. Am J Hematol. 2022 Nov;97(11):E404-E407. doi: 10.1002/ajh.26691. Epub 2022 Sep 2. No abstract available.
PubMed 36053823
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer
- ClinicalTrials.gov ID
- NCT04666025
- Acronym / sponsor ID
- 20153
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection, medical chart review) | – | Procedure: Biospecimen Collection, Other: Diagnostic Laboratory Biomarker Analysis, Other: Electronic Health Record Review, Other: Questionnaire AdministrationDONORS: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (donors and recipients) scheduled to undergo a standard of care donor HCT procedure.
Key inclusion criteria (16 listed)
- 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:
- ALL COHORTS: Willingness to
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of nasopharyngeal swabs, blood, and saliva samples | Procedure or surgery | Observational (biospecimen collection, medical chart review) |
| Diagnostic Laboratory Biomarker AnalysisCorrelative studies | Other | Observational (biospecimen collection, medical chart review) |
| Electronic Health Record ReviewMedical charts are reviewed | Other | Observational (biospecimen collection, medical chart review) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (biospecimen collection, medical chart review) |
Primary outcome
Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels
Time frame: Up to 180 days post-hematopoietic stem cell transplant (HCT)
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S will be measured as a correlate of immunity transfer efficiency.
SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels
Time frame: Up to 180 days post-HCT
Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed ELISA. The qualitative assays will be developed to investigate nucleocapsid (N)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 N antigens will be measured as a correlate of immunity transfer efficiency.
SARS-CoV-2 neutralizing antibodies
Time frame: Up to 180 days post-HCT
Evaluation of SARS-CoV-2 neutralizing antibody titers in serum samples will be performed using SARS-CoV-2 lentiviral-pseudovirus based on published protocols. Spike incorporation into the pseudovirus will be verified and quantified by western blot using Spike-specific antibodies (Sino Biological) and by ELISA using Spike Detection kit (Sino Biological), respectively.
1 secondary outcome
SARS-CoV-2 IgA concentration
Time frame: Up to 180 days post-HCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 36936918La Rosa C, Chiuppesi F, Park Y, Zhou Q, Yang D, Gendzekhadze K, Ly M, Li J, Kaltcheva T, Ortega Francisco S, Gutierrez MA, Ali H, Otoukesh S, Amanam I, Salhotra A, Pullarkat VA, Aldoss I, Rosenzweig M, Aribi AM, Stein AS, Marcucci G, Dadwal SS, Nakamura R, Forman SJ, Al Malki MM, Diamond DJ. Functional SARS-CoV-2-specific T cells of donor origin in allogeneic stem cell transplant recipients of a T-cell-replete infusion: A prospective observational study. Front Immunol. 2023 Mar 3;14:1114131. doi: 10.3389/fimmu.2023.1114131. eCollection 2023.
- Derived from this study: PubMed 36053823La Rosa C, Chiuppesi F, Park Y, Gendzekhadze K, Zhou Q, Faircloth K, Kaltcheva T, Johnson D, Ortega Francisco S, Amanam I, Otoukesh S, Pullarkat VA, Nakamura R, Diamond DJ, Forman SJ, Al Malki MM. Adoptive transfer of functional SARS-COV-2-specific immunity from donor graft to hematopoietic stem cell transplant recipients. Am J Hematol. 2022 Nov;97(11):E404-E407. doi: 10.1002/ajh.26691. Epub 2022 Sep 2. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monzr M Al Malki principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accelerated Phase CML, BCR-ABL1 Positive and Acute Lymphoblastic Leukemia, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels (time frame: Up to 180 days post-hematopoietic stem cell transplant (HCT)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666025, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.