Abstract
The incidence and risk factors for severe adverse events (SAEs) in related donors (RD) of hematopoietic cell transplants is unknown. The Related Donor Safe study is a prospective observational cohort of 1680 RDs and represents an opportunity to examine characteristics of SAEs in RDs. In this cohort, we found that SAEs were reported in a total 12 (0.71%) RDs. Of these, 5 SAEs occurred in bone marrow donors (5/404, 1.24%), and 7 (7/1276, 0.55%) were in donors of peripheral blood stem cells. All of the SAEs were considered to be related (definite, probable, or possible) to the donation process. There were no donor fatalities. Of the 12 RDs who experienced an SAE, 10 were either overweight or obese. Five of the 12 RDs had predonation medical conditions that would have resulted in either possible or definite ineligibility for donation were they being assessed as unrelated donors. These SAE data will be useful in the counseling of prospective RDs before planned donation and may be helpful in identifying donors who should be considered medically unsuitable for donation.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 352.e1-352.e5 |
| Journal | Transplantation and Cellular Therapy |
| Volume | 27 |
| Issue number | 4 |
| DOIs | |
| State | Published - Apr 2021 |
Keywords
- Adverse events
- Allogeneic hematopoietic cell transplantation
- Related donors
ASJC Scopus subject areas
- Hematology
- Transplantation
- Immunology and Allergy
- Cell Biology
- Molecular Medicine
- Medicine(all)
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In: Transplantation and Cellular Therapy, Vol. 27, No. 4, 04.2021, p. 352.e1-352.e5.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Serious Adverse Events in Related Donors
T2 - A Report from the Related Donor Safe Study
AU - Seftel, Matthew D.
AU - Chitphakdithai, Pintip
AU - Miller, John P.
AU - Kobusingye, Hati
AU - Logan, Brent R.
AU - Linenberger, Michael
AU - Artz, Andrew S.
AU - Haight, Ann E.
AU - Jacobsohn, David A.
AU - Litzow, Mark R.
AU - Magalhaes-Silverman, Margarida
AU - Selby, George B.
AU - Vusirikala, Madhuri
AU - Horowitz, Mary M.
AU - Switzer, Galen E.
AU - Confer, Dennis L.
AU - Shaw, Bronwen E.
AU - Pulsipher, Michael A.
N1 - Funding Information: Staff of the CIBMTR and NMDP provided administrative personnel, statistical analyses, and software support for this study. Stephanie Bo-Subait assisted with manuscript preparation. Financial disclosure: Supported by R01 HL085707 through the NHLBI, the Center for International Blood and Marrow Transplantation (CIBMTR) and National Marrow Donor Program (NMDP). The CIBMTR is supported primarily by Public Health Service U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); U24HL138660 from NHLBI and NCI; OT3HL147741, R21HL140314 and U01HL128568 from the NHLBI; HHSH250201700006C, SC1MC31881-01-00 and HHSH250201700007C from the Health Resources and Services Administration (HRSA); and N00014-18-1-2850, N00014-18-1-2888, and N00014-20-1-2705 from the Office of Naval Research; additional federal support is provided by P01CA111412, R01CA152108, R01CA215134, R01CA218285, R01CA231141, R01HL126589, R01AI128775, R01HL129472, R01HL130388, R01HL131731, U01AI069197, U01AI126612, and BARDA. Support is also provided by Be the Match Foundation, Boston Children's Hospital, Dana Farber, Japan Hematopoietic Cell Transplantation Data Center, St. Baldrick's Foundation, the National Marrow Donor Program, the Medical College of Wisconsin and from the following commercial entities: AbbVie; Actinium Pharmaceuticals, Inc.; Adaptive Biotechnologies; Adienne SA; Allovir, Inc.; Amgen, Inc.; Anthem, Inc.; Astellas Pharma US; AstraZeneca; Atara Biotherapeutics, Inc.; bluebird bio, Inc.; Bristol Myers Squibb Co.; Celgene Corp.; Chimerix, Inc.; CSL Behring; CytoSen Therapeutics, Inc.; Daiichi Sankyo Co. Ltd.; Gamida-Cell, Ltd.; Genzyme; GlaxoSmithKline (GSK); HistoGenetics, Inc.; Incyte Corporation; Janssen Biotech, Inc.; Janssen Pharmaceuticals, Inc.; Janssen/Johnson & Johnson; Jazz Pharmaceuticals, Inc.; Kiadis Pharma; Kite Pharma; Kyowa Kirin; Legend Biotech; Magenta Therapeutics; Mallinckrodt LLC; Medac GmbH; Merck & Company, Inc.; Merck Sharp & Dohme Corp.; Mesoblast; Millennium, the Takeda Oncology Co.; Miltenyi Biotec, Inc.; Novartis Oncology; Novartis Pharmaceuticals Corporation; Omeros Corporation; Oncoimmune, Inc.; Orca Biosystems, Inc.; Pfizer, Inc.; Phamacyclics, LLC; Regeneron Pharmaceuticals, Inc.; REGiMMUNE Corp.; Sanofi Genzyme; Seattle Genetics; Sobi, Inc.; Takeda Oncology; Takeda Pharma; Terumo BCT; Viracor Eurofins and Xenikos BV. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. Conflict of interest statement: There are no conflicts of interest to report. Authorship statement: Dr Seftel analyzed the data and wrote the first draft of the manuscript. Dr Shaw analyzed the data, reviewed, edited and approved the final manuscript. Dr Pulshipher led the study, analyzed the data, reviewed, edited and reviewed the final manuscript. Drs. Chitphakdithai, Miller, Kobusingye, Logan, Linenberger, Artz, Haight, Jacobsohn, Litzow, Magalhaes-Silverman, Selby, Vusirikala, Horowitz, Switzer and Confer reviewed, edited and approved the final manuscript. Financial disclosure: See Acknowledgments on page 352.e2. Funding Information: Financial disclosure: Supported by R01 HL085707 through the NHLBI, the Center for International Blood and Marrow Transplantation (CIBMTR) and National Marrow Donor Program (NMDP). The CIBMTR is supported primarily by Public Health Service U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); U24HL138660 from NHLBI and NCI; OT3HL147741, R21HL140314 and U01HL128568 from the NHLBI; HHSH250201700006C, SC1MC31881-01-00 and HHSH250201700007C from the Health Resources and Services Administration (HRSA); and N00014-18-1-2850, N00014-18-1-2888, and N00014-20-1-2705 from the Office of Naval Research; additional federal support is provided by P01CA111412, R01CA152108, R01CA215134, R01CA218285, R01CA231141, R01HL126589, R01AI128775, R01HL129472, R01HL130388, R01HL131731, U01AI069197, U01AI126612, and BARDA. Support is also provided by Be the Match Foundation, Boston Children's Hospital, Dana Farber, Japan Hematopoietic Cell Transplantation Data Center, St. Baldrick's Foundation, the National Marrow Donor Program, the Medical College of Wisconsin and from the following commercial entities: AbbVie; Actinium Pharmaceuticals, Inc.; Adaptive Biotechnologies; Adienne SA; Allovir, Inc.; Amgen, Inc.; Anthem, Inc.; Astellas Pharma US; AstraZeneca; Atara Biotherapeutics, Inc.; bluebird bio, Inc.; Bristol Myers Squibb Co.; Celgene Corp.; Chimerix, Inc.; CSL Behring; CytoSen Therapeutics, Inc.; Daiichi Sankyo Co., Ltd.; Gamida-Cell, Ltd.; Genzyme; GlaxoSmithKline (GSK); HistoGenetics, Inc.; Incyte Corporation; Janssen Biotech, Inc.; Janssen Pharmaceuticals, Inc.; Janssen/Johnson & Johnson; Jazz Pharmaceuticals, Inc.; Kiadis Pharma; Kite Pharma; Kyowa Kirin; Legend Biotech; Magenta Therapeutics; Mallinckrodt LLC; Medac GmbH; Merck & Company, Inc.; Merck Sharp & Dohme Corp.; Mesoblast; Millennium, the Takeda Oncology Co.; Miltenyi Biotec, Inc.; Novartis Oncology; Novartis Pharmaceuticals Corporation; Omeros Corporation; Oncoimmune, Inc.; Orca Biosystems, Inc.; Pfizer, Inc.; Phamacyclics, LLC; Regeneron Pharmaceuticals, Inc.; REGiMMUNE Corp.; Sanofi Genzyme; Seattle Genetics; Sobi, Inc.; Takeda Oncology; Takeda Pharma; Terumo BCT; Viracor Eurofins and Xenikos BV. The views expressed in this article do not reflect the official policy or position of the National Institute of Health, the Department of the Navy, the Department of Defense, Health Resources and Services Administration (HRSA) or any other agency of the U.S. Government. Publisher Copyright: © 2021 The American Society for Transplantation and Cellular Therapy
PY - 2021/4
Y1 - 2021/4
N2 - The incidence and risk factors for severe adverse events (SAEs) in related donors (RD) of hematopoietic cell transplants is unknown. The Related Donor Safe study is a prospective observational cohort of 1680 RDs and represents an opportunity to examine characteristics of SAEs in RDs. In this cohort, we found that SAEs were reported in a total 12 (0.71%) RDs. Of these, 5 SAEs occurred in bone marrow donors (5/404, 1.24%), and 7 (7/1276, 0.55%) were in donors of peripheral blood stem cells. All of the SAEs were considered to be related (definite, probable, or possible) to the donation process. There were no donor fatalities. Of the 12 RDs who experienced an SAE, 10 were either overweight or obese. Five of the 12 RDs had predonation medical conditions that would have resulted in either possible or definite ineligibility for donation were they being assessed as unrelated donors. These SAE data will be useful in the counseling of prospective RDs before planned donation and may be helpful in identifying donors who should be considered medically unsuitable for donation.
AB - The incidence and risk factors for severe adverse events (SAEs) in related donors (RD) of hematopoietic cell transplants is unknown. The Related Donor Safe study is a prospective observational cohort of 1680 RDs and represents an opportunity to examine characteristics of SAEs in RDs. In this cohort, we found that SAEs were reported in a total 12 (0.71%) RDs. Of these, 5 SAEs occurred in bone marrow donors (5/404, 1.24%), and 7 (7/1276, 0.55%) were in donors of peripheral blood stem cells. All of the SAEs were considered to be related (definite, probable, or possible) to the donation process. There were no donor fatalities. Of the 12 RDs who experienced an SAE, 10 were either overweight or obese. Five of the 12 RDs had predonation medical conditions that would have resulted in either possible or definite ineligibility for donation were they being assessed as unrelated donors. These SAE data will be useful in the counseling of prospective RDs before planned donation and may be helpful in identifying donors who should be considered medically unsuitable for donation.
KW - Adverse events
KW - Allogeneic hematopoietic cell transplantation
KW - Related donors
UR - http://www.scopus.com/inward/record.url?scp=85101149566&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85101149566&partnerID=8YFLogxK
U2 - 10.1016/j.jtct.2021.01.009
DO - 10.1016/j.jtct.2021.01.009
M3 - Article
C2 - 33836890
AN - SCOPUS:85101149566
SN - 2666-6375
VL - 27
SP - 352.e1-352.e5
JO - Transplantation and Cellular Therapy
JF - Transplantation and Cellular Therapy
IS - 4
ER -