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1. Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein–Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial

Author

Mahadeo, Kris Michael, Baiocchi, Robert, Beitinjaneh, Amer, Chaganti, Sridhar, Choquet, Sylvain, Dierickx, Daan, Dinavahi, Rajani, Duan, Xinyuan, Gamelin, Laurence, Ghobadi, Armin, Guzman-Becerra, Norma, Joshi, Manher, Mehta, Aditi, Navarro, Willis H, Nikiforow, Sarah, O'Reilly, Richard J, Reshef, Ran, Ruiz, Fiona, Spindler, Tassja, and Prockop, Susan

Published
2024
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3. Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies: The BMT CTN-0903/AMC-080 Trial

Author

Ambinder, Richard F., Wu, Juan, Logan, Brent, Durand, Christine M., Shields, Ryan, Popat, Uday R., Little, Richard F., McMahon, Deborah K., Cyktor, Joshua, Mellors, John W., Ayala, Ernesto, Kaplan, Lawrence D., Noy, Ariela, Jones, Richard J., Howard, Alan, Forman, Stephen J., Porter, David, Arce-Lara, Carlos, Shaughnessy, Paul, Sproat, Lisa, Hashmi, Shahrukh K., Mendizabal, Adam M., Horowitz, Mary M., Navarro, Willis H., and Alvarnas, Joseph C.

Published
2019
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4. Higher Risks of Toxicity and Incomplete Recovery in 13- to 17-Year-Old Females after Marrow Donation: RDSafe Peds Results

Author

Pulsipher, Michael A., Logan, Brent R., Kiefer, Deidre M., Chitphakdithai, Pintip, Riches, Marcie L., Rizzo, J. Douglas, Anderlini, Paolo, Leitman, Susan F., Varni, James W., Kobusingye, Hati, Besser, RaeAnne M., Miller, John P., Drexler, Rebecca J., Abdel-Mageed, Aly, Ahmed, Ibrahim A., Ball, Edward D., Bolwell, Brian J., Bunin, Nancy J., Cheerva, Alexandra, Delgado, David C., Dvorak, Christopher C., Gillio, Alfred P., Hahn, Theresa E., Hale, Gregory A., Haight, Ann E., Hayes-Lattin, Brandon M., Kasow, Kimberly A., Linenberger, Michael, Magalhaes-Silverman, Margarida, Mori, Shahram, Prasad, Vinod K., Quigg, Troy C., Sahdev, Indira, Schriber, Jeffrey R., Shenoy, Shalini, Tse, William T., Yanik, Gregory A., Navarro, Willis H., Horowitz, Mary M., Confer, Dennis L., Shaw, Bronwen E., and Switzer, Galen E.

Published
2019
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9. Autologous hematopoietic cell transplantation for HIV-related lymphoma: results of the BMT CTN 0803/AMC 071 trial

Author

Alvarnas, Joseph C., Le Rademacher, Jennifer, Wang, Yanli, Little, Richard F., Akpek, Gorgun, Ayala, Ernesto, Devine, Steven, Baiocchi, Robert, Lozanski, Gerard, Kaplan, Lawrence, Noy, Ariela, Popat, Uday, Hsu, Jack, Morris, Lawrence E., Jr, Thompson, Jason, Horowitz, Mary M., Mendizabal, Adam, Levine, Alexandra, Krishnan, Amrita, Forman, Stephen J., Navarro, Willis H., and Ambinder, Richard

Published
2016
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10. Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program

Author

Pulsipher, Michael A., Chitphakdithai, Pintip, Logan, Brent R., Shaw, Bronwen E., Wingard, John R., Lazarus, Hillard M., Waller, Edmund K., Seftel, Matthew, Stroncek, David F., Lopez, Angela M., Maharaj, Dipnarine, Hematti, Peiman, O'Donnell, Paul V., Loren, Alison W., Leitman, Susan F., Anderlini, Paolo, Goldstein, Steven C., Levine, John E., Navarro, Willis H., Miller, John P., and Confer, Dennis L.

Published
2013
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12. Obesity Does Not Preclude Safe and Effective Myeloablative Hematopoietic Cell Transplantation (HCT) for Acute Myelogenous Leukemia (AML) in Adults

Author

Navarro, Willis H., Agovi, Manza-A., Logan, Brent R., Ballen, Karen, Bolwell, Brian J., Frangoul, Haydar, Gupta, Vikas, Hahn, Theresa, Ho, Vincent T., Juckett, Mark, Lazarus, Hillard M., Litzow, Mark R., Liesveld, Jane L., Moreb, Jan S., Marks, David I., McCarthy, Philip L., Pasquini, Marcelo C., and Rizzo, J. Douglas

Published
2010
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15. Second Autologous Stem Cell Transplantation for Relapsed Lymphoma after a Prior Autologous Transplant

Author

Smith, Sonali M., van Besien, Koen, Carreras, Jeanette, Bashey, Asad, Cairo, Mitchell S., Freytes, Cesar O., Gale, Robert Peter, Hale, Gregory A., Hayes-Lattin, Brandon, Holmberg, Leona A., Keating, Armand, Maziarz, Richard T., McCarthy, Philip L., Navarro, Willis H., Pavlovsky, Santiago, Schouten, Harry C., Seftel, Matthew, Wiernik, Peter H., Vose, Julie M., Lazarus, Hillard M., and Hari, Parameswaran

Published
2008
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17. 80 - Update on Comparative Analysis of Immune Reconstitution in HIV-Positive Recipients of Allogeneic and Autologous Stem Cell Transplant on the BMT CTN 0903/AMC-080 and BMT CTN 0803/AMC-071 Trials

Author

Shindiapina, Polina, Pietrzak, Maciej, Seweryn, Michal, McLaughlin, Eric, Zhang, Xiaoli, Makowski, Mat, Ahmed, Elshafa, Pearson, Rebecca, Kitzler, Rhonda, Le-Rademacher, Jennifer G., Little, Richard F, Akpek, Görgün, Ayala, Ernesto, Devine, Steven M., Kaplan, Lawrence D., Noy, Ariela, Popat, Uday R., Hsu, Jack W., Morris, Lawrence E, Mendizabal, Adam, Wachsman, William, Williams, Nita, Sharma, Nidhi, Hofmeister, Craig C, Forman, Stephen J., Navarro, Willis H., Alvarnas, Joseph C., Ambinder, Richard F., Malvestutto, Carlos, Choe, Hannah, Behbehani, Gregory, Lozanski, Gerard, Blaser, Bradley, and Baiocchi, Robert

Published
2023
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26. Comparative Analysis of Immune Reconstitution in HIV-Positive Recipients of Allogeneic and Autologous Stem Cell Transplant on the BMT-CTN-0903/AMC-080 and BMT-CTN-0803/AMC-071 Trials

Author

Shindiapina, Polina, Pietrzak, Maciej, Seweryn, Michal, McLaughlin, Eric, Zhang, Xiaoli, Makowski, Mat, Lyberger, Justin, Chang, Hsiaochi, Ahmed, Elshafa, Pearson, Rebecca, Kitzler, Rhonda, Le-Rademacher, Jennifer G., Little, Richard F., Akpek, Görgün, Ayala, Ernesto, Devine, Steven M., Kaplan, Lawrence D., Noy, Ariela, Popat, Uday R., Hsu, Jack W., Morris, Lawrence E., Mendizabal, Adam, Krishnan, Amrita, Hofmeister, Craig C., Forman, Stephen J., Navarro, Willis H., Alvarnas, Joseph C., Ambinder, Richard F., Behbehani, Gregory, Lozanski, Gerard, and Baiocchi, Robert

Published
2020
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27. Long-Term Outcomes of Patients with Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disease Following Solid Organ Transplant or Allogeneic Hematopoietic Cell Transplant Treated with Tabelecleucel in a Multicenter Expanded Access Program Study

Author

Prockop, Susan E, Reshef, Ran, Tsai, Donald E, Bunin, Nancy, Abu-Arja, Rolla, Mahadeo, Kris Michael, Weng, Wen-Kai, van Besien, Koen, Loeb, David, Nasta, Sunita Dwivedy, Nemecek, Eneida R., Hiremath, Minoti, Yue, Susan, Sun, Yan, Navarro, Willis H., and Nikiforow, Sarah

Published
2020
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28. Comparative Analysis of Immune Reconstitution in HIV-Positive Recipients of Allogeneic and Autologous Stem Cell Transplant on the BMT CTN 0903/AMC-080 and BMT CTN 0803/AMC-071 Trials

Author

Shindiapina, Polina, Pietrzak, Maciej, Seweryn, Michal, McLaughlin, Eric, Zhang, Xiaoli, Makowski, Mateusz, Lyberger, Justin, Chang, Hsiaochi, Ahmed, Elshafa Hassan, Prouty, Alexander, Pearson, Rebecca, Kitzler, Rhonda, Le-Rademacher, Jennifer, Little, Richard F., Akpek, Gorgun, Ayala, Ernesto, Devine, Steven, Noy, Ariela, Kaplan, Lawrence D, Popat, Uday, Hsu, Jack W., Morris, Lawrence E, Mendizabal, Adam M., Hofmeister, Craig C, Wachsman, William, Forman, Stephen J, Navarro, Willis H., Alvarnas, Joseph C., Ambinder, Richard F., Behbehani, Gregory K., Lozanski, Gerard, and Baiocchi, Robert A

Published
2019
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32. Phase 2, multicenter, open-label basket trial of nab -sirolimus for patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (PRECISION I).

Author

Iyer, Gopa, Deming, Dustin A., Demeure, Michael J., Federman, Noah, McKean, Meredith, Lee, Elizabeth Katherine, Spira, Alexander I., Kwiatkowski, David J., Hussein, Maen A., Gordon, Erlinda Maria, Crockett, David G., Ganjoo, Kristen N., Schulte, Brian, Cranmer, Lee D., Ding, Li, Schmid, Anita N., Navarro, Willis H., and Rodon Ahnert, Jordi

Published
2023
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33. Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (PRECISION I).

Author

Deming, Dustin A., Rodon Ahnert, Jordi, Demeure, Michael J., Federman, Noah, McKean, Meredith, Lee, Elizabeth Katherine, Spira, Alexander I., Kwiatkowski, David J., Hussein, Maen A., Gordon, Erlinda Maria, Crockett, David G., Ganjoo, Kristen N., Schulte, Brian, Cranmer, Lee D., Schmid, Anita N., Navarro, Willis H., Itri, Loretta Marie, and Iyer, Gopa

Published
2023
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34. Baseline Symptoms, Female Sex, and Younger Age Are Correlated with Higher Levels of Peri-Collection Pain, Symptoms, and Persistent Discomfort One Year after Related Donor BM and PBSC Donation: An Analysis of the Related Donor Safety Study (RDSafe)

Author

Pulsipher, Michael A., Logan, Brent R., Kiefer, Deidre M., Chitphakdithai, Pintip, Switzer, Galen E., Riches, Marcie L, Rizzo, J. Douglas, Anderlini, Paolo, Leitman, Susan F., Varni, James W, Hays, Amy, Kobusingye, Hati, Besser, RaeAnne M., Miller, John P., Drexler, Rebecca J., King, Roberta J., Horowitz, Mary M., Navarro, Willis H., and Confer, Dennis L.

Published
2014
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36. Related PBSC Donors Age >60 Have High Rates of Baseline and Donation-Related Pain and Slow Recovery: First Report from the Related Donor Safety Study (RDSafe)

Author

Pulsipher, Michael A., Chitphakdithai, Pintip, Logan, Brent R., Switzer, Galen E., Tomblyn, Marcie R., Rizzo, J. Douglas, Anderlini, Paolo, Leitman, Susan F., Varni, James W., Hays, Amy, Kobusingye, Hati, Miller, John P., Drexler, Rebecca J., King, Roberta, Horowitz, Mary M., Confer, Dennis L., and Navarro, Willis H.

Published
2014
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37. Phase I/II Multicenter Clinical Trial of Lenalidomide Maintenance After Allogeneic Hematopoietic Cell Transplant (alloHCT) in Patients with High Risk (HR) Multiple Myeloma (MM)

Author

Becker, Pamela S., Alsina, Melissa, Zhong, Xiaobo, Hari, Parameswaran N., Rowley, Scott, Stadtmauer, Edward A., Vesole, David, Logan, Brent R., Weisdorf, Daniel J., Qazilbash, Muzaffar, Popplewell, Leslie, Navarro, Willis H., Tomblyn, Marcie, Giralt, Sergio A., and Pasquini, Marcelo C.

Published
2013
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40. Significant and Rapid Improvement in Survival After Unrelated Donor (URD) Hematopoietic Cell Transplantation (HCT): Analysis of National Marrow Donor Program (NMDP) Facilitated Transplants From 2000 to 2009

Author

Majhail, Navneet S., Chitphakdithai, Pintip, Shan, Ying, King, Roberta, Anton, Bernadette, Ashton, Robyn, Bakken, Ruth, Braem, Bette, Devine, Steven M., Hale, Gregory A., Hartzman, Robert J, Karanes, Chatchada, Laport, Ginna G, Lewis, Rebecca, Nemecek, Eneida R., Rossmann, Susan, Shawir, Nawraz, Snyder, Edward L., Switzer, Galen E., Navarro, Willis H., Miller, John P., Confer, Dennis L, and Levine, John E.

Published
2012
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42. Obesity and lymphoma therapy: not a bad combination after all.

Author

Navarro, Willis H. and Loberiza, Fausto R.

Subjects
*B cell lymphoma, *METABOLIC disorders, *OBESITY, *LYMPHOMA treatment, *DRUG therapy
Abstract

In this article, authors comment on the retrospective analysis of the impact of obesity on outcomes for intermediate- grade B-cell lymphomas. As stated, patients for the analysis were enrolled on clinical trials in which chemotherapy dosing was not adjusted for obesity. Authors opine, the study convincingly demonstrate patients with IGBCL, irrespective of weight, should receive full dose chemotherapy.

Published
2010
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43. Lower risk for serious adverse events and no increased risk for cancer after PBSC vs BM donation.

Author

Pulsipher, Michael A., Chitphakdithai, PIntip, Logan, Brent R., Navarro, Willis H., Levine, John E., Miller, John P., Shaw, Bronwen E., O'Donnell, Paul V., Majhail, Navneet S., and Confer, Dennis L.

Subjects
*CANCER, *BONE marrow, *AUTOIMMUNE diseases, *STEM cells, *GRANULOCYTES, *STROKE
Abstract

We compared serious early and late events experienced by 2726 bone marrow (BM) and 6768 peripheral blood stem cell (PBSC) donors who underwent collection of PBSC or BM between 2004 and 2009 as part of a prospective study through the National Marrow Donor Program. Standardized FDA definitions for serious adverse events (SAEs) were used, and all events were reviewed by an independent physician panel. BM donors had an increased risk for SAEs (2.38% for BM vs 0.56% for PBSC; odds ratio [OR], 4.13; P< .001), and women were twice as likely to experience an SAE (OR for men, 0.50; P = .005). Restricting the analysis to life-threatening, unexpected, or chronic/disabling events, BM donors maintained an increased risk for SAEs (0.99% for BM vs 0.31% for PBSC; OR, 3.20; P< .001). Notably, the incidence of cancer, autoimmune Illness, and thrombosis after donation was similar in BM vs PBSC donors. In addition, cancer incidence in PBSC donors was less than that reported in the general population (Surveillance, Epidemiology, and End Results Program database). In conclusion, SAEs after donation are rare but more often occurred in BM donors and women. In addition, there was no evidence of increased risk for cancer, autoimmune illness, and stroke in donors receiving granulocyte colony-stimulating factor during this period of observation. [ABSTRACT FROM AUTHOR]

Published
2014
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44. Immune Recovery Following Autologous Hematopoietic Stem Cell Transplantation in HIV-Related Lymphoma Patients on the BMT CTN 0803/AMC 071 Trial.

Author

Shindiapina P, Pietrzak M, Seweryn M, McLaughlin E, Zhang X, Makowski M, Ahmed EH, Schlotter S, Pearson R, Kitzler R, Mozhenkova A, Le-Rademacher J, Little RF, Akpek G, Ayala E, Devine SM, Kaplan LD, Noy A, Popat UR, Hsu JW, Morris LE, Mendizabal AM, Krishnan A, Wachsman W, Williams N, Sharma N, Hofmeister CC, Forman SJ, Navarro WH, Alvarnas JC, Ambinder RF, Lozanski G, and Baiocchi RA

Subjects
Clinical Trials, Phase II as Topic, Humans, Transplantation, Autologous methods, HIV Infections immunology, HIV Infections therapy, Hematopoietic Stem Cell Transplantation, Immune Reconstitution immunology, Lymphoma, AIDS-Related therapy
Abstract

We report a first in-depth comparison of immune reconstitution in patients with HIV-related lymphoma following autologous hematopoietic cell transplant (AHCT) recipients (n=37, lymphoma, BEAM conditioning), HIV(-) AHCT recipients (n=30, myeloma, melphalan conditioning) at 56, 180, and 365 days post-AHCT, and 71 healthy control subjects. Principal component analysis showed that immune cell composition in HIV(+) and HIV(-) AHCT recipients clustered away from healthy controls and from each other at each time point, but approached healthy controls over time. Unsupervised feature importance score analysis identified activated T cells, cytotoxic memory and effector T cells [higher in HIV(+)], and naïve and memory T helper cells [lower HIV(+)] as a having a significant impact on differences between HIV(+) AHCT recipient and healthy control lymphocyte composition (p<0.0033). HIV(+) AHCT recipients also demonstrated lower median absolute numbers of activated B cells and lower NK cell sub-populations, compared to healthy controls (p<0.0033) and HIV(-) AHCT recipients (p<0.006). HIV(+) patient T cells showed robust IFNγ production in response to HIV and EBV recall antigens. Overall, HIV(+) AHCT recipients, but not HIV(-) AHCT recipients, exhibited reconstitution of pro-inflammatory immune profiling that was consistent with that seen in patients with chronic HIV infection treated with antiretroviral regimens. Our results further support the use of AHCT in HIV(+) individuals with relapsed/refractory lymphoma., Competing Interests: PS, Seattle Genetics, Research funding. AK, Celgene, Consultancy, Speakers Bureau, Millennium/Takeda, Consultancy, Speakers Bureau, Onyx, Consultancy, Speakers Bureau, Janssen, Consultancy, Speakers Bureau. Hofmeister, Signal Genetics, Inc., Membership on an entity’s Board of Directors or advisory committees, Celgene, Research Funding; Arno Therapeutics, Inc., Research Funding, Incyte, Corp, Membership on an entity’s Board of Directors or advisory committees, Janssen, Pharmaceutical Companies of Johnson & Johnson, Research Funding, Karyopharm Therapeutics, Research Funding, Takeda Pharmaceutical Company, Research Funding, Teva, Membership on an entity’s Board of Directors or advisory committees. SF, Mustang Therapeutics, Other, Construct licensed by City of Hope. WN, Atara Biotherapeutics, employment, stock ownership. GL, Boehringer Ingelheim, Research Funding, Beckman Coulter, Research Funding, Stemline Therapeutics Inc., Research Funding, Genentech. RB, Prelude Therapeutics, Research Funding and Scientific Advisory Board, Viracta, Scientific Advisory Board. AN, Janssen, Membership on a Board or Advisory Committee; Medscape, Honoraria; Morphosys, Membership on a Board or Advisory Committee; Pharmacyclics, Research Funding, Honoraria; Rafael Pharma, Research Funding; Epizyme, Membership on a Board or Advisory Committee; Physician Education Resource, Consulting. MM and AMM are employed by EMMES Company. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Shindiapina, Pietrzak, Seweryn, McLaughlin, Zhang, Makowski, Ahmed, Schlotter, Pearson, Kitzler, Mozhenkova, Le-Rademacher, Little, Akpek, Ayala, Devine, Kaplan, Noy, Popat, Hsu, Morris, Mendizabal, Krishnan, Wachsman, Williams, Sharma, Hofmeister, Forman, Navarro, Alvarnas, Ambinder, Lozanski and Baiocchi.)

Published
2021
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45. First-in-Human Phase I Study of the Activin A Inhibitor, STM 434, in Patients with Granulosa Cell Ovarian Cancer and Other Advanced Solid Tumors.

Author

Tao JJ, Cangemi NA, Makker V, Cadoo KA, Liu JF, Rasco DW, Navarro WH, Haqq CM, and Hyman DM

Subjects
Activins, Granulosa Cells, Humans, Maximum Tolerated Dose, Treatment Outcome, Antineoplastic Agents, Neoplasms, Ovarian Neoplasms
Abstract

Purpose: STM 434 is a soluble receptor ligand trap targeting activin A, a protein in the TGFβ family that plays important roles in growth, differentiation, and cancer cachexia. This study evaluated the safety, antitumor activity, and metabolic effects of STM 434 in a first-in-human, multicenter, phase I clinical trial (NCT02262455)., Patients and Methods: Patients with advanced solid tumors were enrolled in 8 dose cohorts ranging from 0.25 mg/kg every 4 weeks to 8 mg/kg every 2 weeks via a 3 + 3 dose-escalation design. The primary endpoint was maximum tolerated dose (MTD). Secondary endpoints included safety, pharmacokinetics, and response. As activin A is implicated in metabolism and muscle function, changes in key metabolic parameters, including lean body mass and 6-minute walk test, were serially measured., Results: Thirty-two patients were treated on study. The most common treatment-related adverse events were fatigue (41%) and mucocutaneous bleeding complications including epistaxis (34%) and gingival bleeding (22%), likely related to off-target inhibition of bone morphogenetic protein 9 (BMP9). STM 434 treatment resulted in the expected follicle-stimulating hormone level decreases in most patients and in metabolic parameter changes, including an increase in total lean body mass and 6-minute walk test distance. No responses were observed in the 30 evaluable patients, but the stable disease rate in patients with granulosa cell ovarian cancer was 10 of 12 (80%)., Conclusions: Although no direct antitumor efficacy was documented, potentially clinically meaningful dose-related metabolic effects, including treatment of cancer cachexia, were observed that support further exploration of activin A inhibitors that limit BMP9 blockade. See related commentary by Bonilla and Oza, p. 5432 ., (©2019 American Association for Cancer Research.)

Published
2019
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46. Effect of Aging and Predonation Comorbidities on the Related Peripheral Blood Stem Cell Donor Experience: Report from the Related Donor Safety Study.

Author

Pulsipher MA, Logan BR, Chitphakdithai P, Kiefer DM, Riches ML, Rizzo JD, Anderlini P, Leitman SF, Varni JW, Kobusingye H, Besser RM, Miller JP, Drexler RJ, Abdel-Mageed A, Ahmed IA, Akard LP, Artz AS, Ball ED, Bayer RL, Bigelow C, Bolwell BJ, Broun ER, Bunin NJ, Delgado DC, Duckworth K, Dvorak CC, Hahn TE, Haight AE, Hari PN, Hayes-Lattin BM, Jacobsohn DA, Jakubowski AA, Kasow KA, Lazarus HM, Liesveld JL, Linenberger M, Litzow MR, Longo W, Magalhaes-Silverman M, McCarty JM, McGuirk JP, Mori S, Prasad VK, Rowley SD, Rybka WB, Sahdev I, Schriber JR, Selby GB, Shaughnessy PJ, Shenoy S, Spitzer T, Tse WT, Uberti JP, Vusirikala M, Waller EK, Weisdorf DJ, Yanik GA, Navarro WH, Horowitz MM, Switzer GE, Shaw BE, and Confer DL

Subjects
Adolescent, Adult, Aged, Blood Donors, Comorbidity, Female, Humans, Male, Middle Aged, Young Adult, Peripheral Blood Stem Cell Transplantation methods, Peripheral Blood Stem Cells metabolism
Abstract

The development of reduced-intensity approaches for allogeneic hematopoietic cell transplantation has resulted in growing numbers of older related donors (RDs) of peripheral blood stem cells (PBSCs). The effects of age on donation efficacy, toxicity, and long-term recovery in RDs are poorly understood. To address this we analyzed hematologic variables, pain, donation-related symptoms, and recovery in 1211 PBSC RDs aged 18 to 79 enrolled in the Related Donor Safety Study. RDs aged > 60 had a lower median CD34 + level before apheresis compared with younger RDs (age > 60, 59 × 10 6 /L; age 41 to 60, 81 × 10 6 /L; age 18 to 40, 121 × 10 6 /L; P < .001). This resulted in older donors undergoing more apheresis procedures (49% versus 30% ≥ 2 collections, P < .001) and higher collection volumes (52% versus 32% > 24 L, P < .001), leading to high percentages of donors aged > 60 with postcollection thrombocytopenia <50 × 10 9 /L (26% and 57% after 2 and 3days of collection, respectively). RDs aged 18 to 40 had a higher risk of grades 2 to 4 pain and symptoms pericollection, but donors over age 40 had more persistent pain at 1, 6, and 12 months (odds ratio [OR], 1.7; P = 0.02) and a higher rate of nonrecovery to predonation levels (OR, 1.7; P = .01). Donors reporting comorbidities increased significantly with age, and those with comorbidities that would have led to deferral by National Marrow Donor Program unrelated donor standards had an increased risk for persistent grades 2 to 4 pain (OR, 2.41; P < .001) and failure to recover to predonation baseline for other symptoms (OR, 2.34; P = .004). This information should be used in counseling RDs regarding risk and can assist in developing practice approaches aimed at improving the RD experience for high-risk individuals., (Copyright © 2018 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.)

Published
2019
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47. Related peripheral blood stem cell donors experience more severe symptoms and less complete recovery at one year compared to unrelated donors.

Author

Pulsipher MA, Logan BR, Kiefer DM, Chitphakdithai P, Riches ML, Rizzo JD, Anderlini P, Leitman OF, Kobusingye H, Besser RM, Miller JP, Drexler RJ, Abdel-Mageed A, Ahmed IA, Akard LP, Artz AS, Ball ED, Bayer RL, Bigelow C, Bolwell BJ, Broun ER, Delgado DC, Duckworth K, Dvorak CC, Hahn TE, Haight AE, Hari PN, Hayes-Lattin BM, Jacobsohn DA, Jakubowski AA, Kasow KA, Lazarus HM, Liesveld JL, Linenberger M, Litzow MR, Longo W, Magalhaes-Silverman M, McCarty JM, McGuirk JP, Mori S, Parameswaran V, Prasad VK, Rowley SD, Rybka WB, Sahdev I, Schriber JR, Selby GB, Shaughnessy PJ, Shenoy S, Spitzer T, Tse WT, Uberti JP, Vusirikala M, Waller EK, Weisdorf DJ, Yanik GA, Navarro WH, Horowitz MM, Switzer GE, Confer DL, and Shaw BE

Subjects
Adolescent, Adult, Female, Humans, Male, Middle Aged, Prospective Studies, Young Adult, Living Donors, Peripheral Blood Stem Cell Transplantation, Peripheral Blood Stem Cells, Quality of Life, Unrelated Donors
Abstract

Unlike unrelated donor registries, transplant centers lack uniform approaches to related donor assessment and deferral. To test whether related donors are at increased risk for donation-related toxicities, we conducted a prospective observational trial of 11,942 related and unrelated donors aged 18-60 years. Bone marrow (BM) was collected at 37 transplant and 78 National Marrow Donor Program centers, and peripheral blood stem cells (PBSC) were collected at 42 transplant and 87 unrelated donor centers in North America. Possible presence of medical comorbidities was verified prior to donation, and standardized pain and toxicity measures were assessed pre-donation, peri-donation, and one year following. Multivariate analyses showed similar experiences for BM collection in related and unrelated donors; however, related stem cell donors had increased risk of moderate [odds ratios (ORs) 1.42; P <0.001] and severe (OR 8.91; P <0.001) pain and toxicities (OR 1.84; P <0.001) with collection. Related stem cell donors were at increased risk of persistent toxicities (OR 1.56; P =0.021) and non-recovery from pain (OR 1.42; P =0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P <0.001) and non-recovery from toxicities (OR 3.71; P <0.001) at one year. Related donors with more significant comorbidities were at especially high risk for grade 2-4 pain (OR 3.43; P <0.001) and non-recovery from toxicities (OR 3.71; P <0.001) at one year. Related donors reporting grade ≥2 pain had significant decreases in Health-Related Quality of Life (HR-QoL) scores at one month and one year post donation ( P =0.004). In conclusion, related PBSC donors with comorbidities are at increased risk for pain, toxicity, and non-recovery at one year after donation. Risk profiles described in this study should be used for donor education, planning studies to improve the related donor experience, and decisions regarding donor deferral. Registered at clinicaltrials.gov identifier:00948636 ., (Copyright© 2019 Ferrata Storti Foundation.)

Published
2019
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