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November 2020 Newsletter

Volume 26, Issue 4

Perspectives: The Best of the Best

By John Wingard, MD

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Before our kids were launched to the adult world, every winter holiday our family would gather before the fireplace (yes, homes in Florida really have fireplaces) and TV to watch various shows that recap the best songs, bands, news events, whatever. Some of our family's fondest memories revolve around this shared experience. One year, my mild-mannered son uttered an expletive in disgust at the top song and stormed out of the room—to the glee of his sisters. That moment has achieved mythic significance in our family lore and always brings a chuckle when we recall it. We even played the song at his wedding reception. How the cable show producers came up with the rankings was mysterious and probably reflected their personal tastes (who were no more expert than you or me). Nonetheless, we enjoyed the songs and our lively debates as to the merits of the selections.

So, for this newsletter, I thought I would offer an equally unscientific list of bests: Which CIBMTR studies in 2019 were the best—at least for me. I chose to ignore impact factors and citation numbers, all the "scientific metrics" we usually track for impact, and instead focused on just selecting what I like and, in particular, studies I think illustrate new pivots for an aged clinical database.

Best study to influence public policy. Myelodysplastic syndrome (MDS) is a disease of the elderly. In the US, Medicare insures most individuals aged 65 and older and for years declined to cover HCT for MDS, due to a lack of evidence in people aged older than 65. The Catch 22 logic is unmistakable: No data could be obtained because it was not a covered benefit. Through masterly negotiation, a demonstration project was launched, transplants were done, and data were gathered (1). The findings: Patients up to 75 did as well as patients 55-65. Did policy change? Drum roll: Stay tuned, government moves glacially.

Best study to engage cooperative group AML investigators with transplanters. Tremendous strides have been made to engage myeloma experts to collaborate with transplanters in clinical trials, but similar collaborative clinical trials in AML have lagged behind. In this study (2), elderly AML patients who did not receive HCT in cooperative group trials were matched to those who did by combining data from both the CIBMTR and a cooperative group. Finding: Patients who received transplants had worse outcomes for the first 9 months, but thereafter transplant recipients did better. Interesting sidebar: Non-transplant controls were difficult to get since most of the patients in the cooperative group trials went on to transplant. Are there more opportunities for prospective trials that we should pursue?

Best study to use the Electronic Medical Record (EMR). With all the misery we have endured by EMRs, we have been searching for some tangible benefit of the EMR. Zinter and colleagues merged the Virtual Pediatric Systems, a database of billing codes drawn from EMRs across US and Canadian pediatric centers. The goal was to develop a model using factors present at or near the time of pediatric ICU admission to predict critical care outcomes (3). The team succeeded in creating a highly predictive model that identified several novel factors and found that combining both HCT and critical care factors led to very accurate forecasts for the risk of death.

Best use of baseline samples we all send to the CIBMTR/NMDP: Several to choose from; I like them all. First, telomere length in peripheral blood samples was assessed in aplastic anemia patients (4). Findings: Short telomere length was associated with high post-transplant mortality, providing greater strength to an association hinted at in earlier smaller studies. Second, Tang et al (5) attempted to validate earlier associations between specific recipient or donor genetic variants with GVHD in a smaller European study. Assessing nearly 3,000 donor-recipient paired samples, the associations could not be validated. While the findings are disappointing, this study illustrates both the false discovery problems that all host genetic variant studies are susceptible to and the power of large sample sizes, such as the CIBMTR's, to interrogate complex systems. Third, Knight et al (6) probed molecular correlates of low socioeconomic status (SES) and the association with HCT outcomes by testing peripheral blood mononuclear cells for up-regulation of pro-inflammatory genes and downregulation of genes associated with interferon response and antibody synthesis. Unfortunately, the findings were not conclusive due to small numbers, compounded by few racial minority patients and few in the lowest SES group. Still, I find this premise fascinating, and I hope more work extends these findings.

These "bests" represent the best work of all of us. None of these studies are possible without all of us reporting our data to the CIBMTR and submitting samples. Each time we think, "Why bother proposing new studies?" when surely we have squeezed every morsel of useful information out of the registry, studies such as these remind me that novel ways to leverage the CIBMTR's data with other data banks or to link clinical data with biological markers are powerful tools to provide new insights into transplant outcomes. Such new pivots are crucial to the CIBMTR in order to continue advancing our field.

Sometimes we focus too much attention on the best and overlook the many worthy works that provide solid contributions that impact the way we practice and think about our work. Often we disagree about what is best. Yet, thinking about the matter stimulates us to reflect upon what we are doing and starts conversations about what criteria we should use in evaluating and prioritizing our work. It invigorates our community. Like my son reminds me, we can have strong feelings about such things while we still value our community, our accomplishments, and our shared experiences.

References

  1. Atallah E, Logan B, Chen M, et al. Comparison of patient age groups in transplantation for myelodysplastic syndrome: The Medicare Coverage with Evidence Development study. JAMA Oncology. 2020 Apr 1; 6(4):486-493. doi:10.1001/jamaoncol.2019.5140
  2. Ustun C, Le-Rademacher J, Wang HL, et al. Allogeneic hematopoietic cell transplantation compared to chemotherapy consolidation in older acute myeloid leukemia (AML) patients 60-75 years in first complete remission (CR1): An Alliance (A151509), SWOG, ECOG-ACRIN, and CIBMTR study. Leukemia. 2019 May 9; 33(11):2599-2609. doi:10.1038/s41375-019-0477-x
  3. Zinter MS, Logan BR, Fretham C, et al. Comprehensive prognostication in critically ill pediatric hematopoietic cell transplant patients: Results from merging the Center for International Blood and Marrow Transplant Research (CIBMTR) and Virtual Pediatric Systems (VPS) registries. Biology of Blood and Marrow Transplantation. 2020 Feb 2; 26(2):333-342. doi:10.1016/j.bbmt.2019.09.027
  4. Wang Y, McReynolds LJ, Dagnall C, et al. Pre-transplant short telomeres are associated with high mortality risk after unrelated donor haematopoietic cell transplant for severe aplastic anaemia. British Journal of Haematology. 2020 Jan 1;188(2):309-316. doi:10.1111/bjh.16153
  5. Tang H, Hahn T, Karaesmen E, et al. Validation of genetic associations with acute GVHD and nonrelapse mortality in DISCOVeRY-BMT. Blood Advances. 2019 Aug 7; 3(15):2337-2341. doi:10.1182/bloodadvances.2019000052
  6. Knight JM, Rizzo JD, Wang T, et al. Molecular correlates of socioeconomic status and clinical outcomes following hematopoietic cell transplantation for leukemia. JNCI Cancer Spectrum. 2019 Sep 12; 3(4):pkz073. doi:10.1093/jncics/pkz073

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Graft Sources and Manipulation Working Committee

Committee Leadership

Co-Chairs:

Scientific Director:

Statistical Director:

Statistician:

The Graft Sources and Manipulation Working Committee addresses scientific questions related to the comparative effectiveness of the three most commonly used graft types, quality, and manipulation. It is one of the most active and prolific committees of the CIBMTR. The committee has collaborated with other registries, both nationally and internationally, and the resulting publications have led to practice changes. Specifically, the committee has influenced change in regards to graft choices when considering HLA-matched sibling and unrelated donor transplantations for leukemia, the use of T-cell depletion in reduced-intensity transplants and pediatric cord blood transplants, selection of cord units, the use of cord blood as a stem cell source for patients with hematological malignancies, and the choice of alternative graft source in patients with acute leukemia. The committee's primary collaborators are Eurocord and the EBMT Acute Leukemia Working Party.

Committee membership is comprised of investigators with diverse backgrounds and experience in clinical transplantation and cell processing and manipulation, providing the opportunity for synergy in scientific interactions, stem cell technology development, and new ideas. The committee has a significant publication track record with 14 publications in the past 5 years, including publications in several high-impact journals, such as Blood and the Journal of Clinical Oncology. The committee's manuscripts had 479 citations, with an average relative citation ratio of 4.47, among the highest of the CIBMTR Working Committees. This committee continues to attract a large number of participants at the in-person meeting (167 in 2020) and received very positive audience feedback regarding previous meetings. Attendees were happy with the preparation of the team and presenters, time available for discussions of new proposals and ongoing studies, quality of the information and access to committee leadership about committee's activities, and - most significant - the majority of people felt welcome to become an investigator.

The committee has a number of ongoing projects that address current issues related to donor and / or graft selection for allogeneic transplantation. In particular, several ongoing studies examine outcomes of T-cell replete haploidentical transplants with post-transplant cyclophosphamide, including comparing myeloablative with reduced-intensity conditioning, and the impact of GCSF administered after in vivo T-cell depleted HCT. With the increase in numbers of matched related and haploidentical, and unrelated donor transplants receiving post-transplant cyclophosphamide, the committee is addressing the impact of this immune prophylaxis strategy on outcomes of HCT using these donor types. The most recently accepted study will compare outcomes from a BMT CTN 1101 (double UCB vs Haplo-BM with ptCy) to those from a contemporaneous cohort from the CIBMTR registry that would have met protocol eligibility. The success of the committee is dependent on scientific interactions, new ideas, and active participation of junior and senior investigators.

Please contact one of the Co-Chairs or the Scientific Director to learn more about the committee or to discuss ideas and new projects.

View planned, in-progress, and completed studies and publications on the Graft Sources and Manipulation Working Committee webpage.

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Late Effects and Quality of Life Working Committee

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Back row left to right: Ruta Brazauskas, Minoo Battiwalla (outgoing chair in 2020), David Buchbinder, Helene Schoemans (incoming chair in 2020), Stephanie Bo-Subait

Front row left to right: Rachel Phelan (newly appointed scientific director), Bronwen Shaw (outgoing scientific director), and Betty Hamilton

Committee Leadership

Co-Chairs:

Scientific Director:

Statistical Director:

Statistician:

The Late Effects and Quality of Life Working Committee conducts clinical research about long-term outcomes after HCT, including the chronic health conditions and psychosocial effects of transplantation. The committee takes advantage of the CIBMTR's large and representative clinical database to study these so-called "late effects," which includes characterizing specific late effects as well as understanding which HCT survivors are at greatest risk for developing these complications. A better understanding of HCT-related late effects is important not only for surveillance in clinical practice but also for the development of new strategies associated with low rates of undesirable late complications of transplantation.

The committee meets annually in-person at the TCT Meetings of ASTCT and CIBMTR. The Co-Chairs, along with the Scientific Director, Statistical Director, and MS Statistician, meet monthly by teleconference to ensure the timely completion of projects and to reassess priority areas and promote and develop the committee's scientific agenda. The 2020 committee meeting, held in Orlando, FL, enjoyed continued strong participation with 171 attendees! Moreover, the productivity and enthusiasm of the committee have resulted in positive evaluations by meeting attendees and the CIBMTR Advisory Committee, which conducts ongoing reviews of the individual committee meetings.

A list of the committee's studies, including recent publications, is provided on the Late Effects and Quality of Life Working Committee webpage. Participant engagement in committee activities is key to the committee's accomplishments.

The committee's extensive portfolio comprises 9 protocols in development, analysis, or manuscripts in preparation. These cover a wide range of topics germane to the care of HCT survivors and their families, such as evaluation of late effects in pediatric and adult survivors of HCT for sickle cell disease and survival and late effects for those patients who spent time in the pediatric ICU as part of their transplant course. The committee has also engaged in collaborative efforts between the CIBMTR and other organizations. As an example, members of the committee have developed a protocol that jointly utilizes the United Network for Organ Sharing (UNOS) and the CIBMTR to evaluate outcomes among HCT survivors that require a subsequent solid organ transplant or vice versa. This is currently in manuscript preparation. One of the committee's recently chosen protocols also involves linking the CIBMTR Research Database with that of the Childhood Cancer Survivor Study (CCSS) to evaluate long-term cardiovascular outcomes in HCT survivors. This year the committee had the opportunity to select two new proposals for subsequent development and analysis. Aside from the CCSS study, the other chosen study analyzes the link between PROs and a defined social transcriptome profile and how this impacts HCT outcomes. Both proposals represent important areas of exploration whose results are vitally important to the HCT community.

Lastly, the Late Effects and Quality of Life Working Committee is involved in other activities, including projects that lead to published reviews targeting areas of post-transplant late effects interest. These projects have created additional opportunities for junior investigators to become actively involved in the committee. Building on a strong history of international collaboration, the committee has worked diligently with EBMT colleagues to develop a process calling for proposals, choose a pertinent late effects topic, and conduct a formal systematic review on the chosen topic. A systematic review focused on male-specific late effects is currently in process, and the committee is excited to continue this effort. 

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The 2021 TCT Meetings of ASTCT and CIBMTR Digital Experience

By Tia Houseman

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The TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR are the combined annual meetings of the ASTCT and CIBMTR. Administrators, clinicians, data manager / clinical research professionals, fellows-in-training, investigators, laboratory technicians, MD / PhDs, nurses, nurse practitioners, pharmacists, physician assistants, and other allied health professional attendees benefit from a full scientific program that addresses the most timely issues in cellular therapy.

While ASTCT and CIBMTR were hopeful to meet in-person at the 2021 TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, protecting our attendees, speakers, supporters, and staff remains our top priority. Large gatherings and travel continue to pose significant health and safety concerns due to COVID-19, making it impossible to hold the meetings at the Hawaii Convention Center in Honolulu, Hawaii, originally scheduled for February 10-14, 2021. 

We are excited to announce that the 2021 TCT Meetings of ASTCT and CIBMTR will transition into The 2021 TCT Meetings of ASTCT and CIBMTR Digital Experience and will take place Monday, February 8 – Friday, February 12, 2021, with various sessions held the weeks of February 1 and 15. Sessions will take place between the hours of approximately 9 am-5 pm CT; however, attendees will have the opportunity to view accredited sessions for an extended amount of time post-session to claim continuing education credit.

Staying on top of the latest scientific updates, innovative ideas, and timeliest issues in cellular therapy are critical. That is why we are committed to bringing you an outstanding digital program, with the opportunity to earn even more continuing education credits. We're confident that The 2021 TCT Meetings of ASTCT and CIBMTR Digital Experience will help inspire and propel you to better reach your professional goals.

Same great content and more – without a flight and hotel

2021 Scientific Organizing Chairs, Leslie Kean, MD, PhD, and Ned Waller, MD, PhD, FACP, along with the scientific organizing committee and session chairs, assembled an excellent program outlining the topics listed below. Throughout The TCT Meetings of ASTCT and CIBMTR Digital Experience, leading cellular therapy experts from around the world will present the latest developments through plenary and concurrent sessions, oral abstracts, posters, tracks, and more.

Scientific Program Topics

  • Acute GVHD: Therapies for new targets
  • Cellular therapies: New platforms and targets
  • Chronic GVHD: Mechanisms and new therapies
  • Creating solutions through international collaboration: Lessons learned during the COVID-19 pandemic
  • Data science and machine learning in transplantation and cellular therapy studies
  • Gene therapy for non-malignant diseases
  • Immunotherapy in myeloma
  • Late effects: Working early to improve long-term outcomes
  • Leukemia: Drugs to decrease relapse
  • NK cellular therapies
  • Oxygen sensing
  • T-Cells: Biology to therapeutics
  • Transplantation and cell therapy during pandemics
  • The microbiome and transplant outcomes
  • The impact of COVID-19 on the global transplant community
  • Pediatric BMT
  • …and more

 

Plus: Mortimer M. Bortin Lecture, E. Donnall Thomas Lecture, late-breaking abstracts, CIBMTR Working Committee meetings, ASTCT Special Interest Group meetings, and Meet-the-Professor sessions. Along with these state-of-the-art educational offerings, industry-supported satellite symposia, product theaters, and exhibitors will broaden the spectrum of presentations even further.

Registration will open soon!

We look forward to having you join us in the first-ever TCT Meetings of ASTCT and CIBMTR Digital Experience in February 2021!

Please continue to check the official TCT Meetings of ASTCT and CIBMTR website for updates.

Support Opportunities and Additional Information

Please direct questions regarding support opportunities for the 2021 TCT Meetings of ASTCT and CIBMTR Digital Experience to the TCT Meetings of ASTCT and CIBMTR Conference Office: TCTMeetings@mcw.edu.

We look forward to seeing you online!

Join the conversation: #TCTM21

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See below for updates on BMT CTN at the ASH Annual Meeting and the TCT Meetings of ASTCT and CIBMTR. We'll be sharing details on the 2021 State of the Science Symposium soon!

BMT CTN at ASH

The BMT CTN is proud again to sponsor the ASH Scientific Workshop on Immune Profiling and MRD Testing in Multiple Myeloma. The agenda is jam-packed with basic science, translational, and clinical presentations, including speakers from the FDA and European Medicines Agency. Please join us:

  • Thursday, December 3, 2020

  • 7:00 – 10:00am PT (10:00am – 1:00pm ET)

BMT CTN 1102 primary study results will be presented at ASH by Corey Cutler, MD, MPH: A multi-center biologic assignment trial comparing reduced-intensity allogeneic hematopoietic cell transplantation to hypomethylating therapy or best supportive care in patients aged 50-75 with advanced myelodysplastic syndrome: Blood and Marrow Transplant Clinical Trials Network study 1102

  • Session Name: 732. Clinical Allogeneic Transplantation: Results I

  • Session Date: Saturday, December 5, 2020

  • Presentation Time: 7:30am PT (10:30am ET)

Also, for those interested in the BMT CTN 1803 (Haplo NK Cell) study design, join Sumithira Vasu, MBBS's Trials in Progress poster presentation:

  • Sunday, December 6, 2020

  • Anytime between 7:00am – 3:30pm PT

BMT CTN at the TCT Meetings of ASTCT and CIBMTR

During the TCT Meetings of ASTCT and CIBMTR, there are usually multiple in-person BMT CTN meetings to provide education and share updates and ideas. Given the virtual nature of the 2021 meetings, we are changing course:

  • The BMT CTN Coordinators meeting will be split into multiple shorter webinars offered throughout 2021

  • The BMT CTN Investigators meeting will not be held in 2021

  • The BMT CTN Multiple Myeloma Intergroup and protocol-specific PI meetings will be held as webinars throughout the year, as needed

We hope to see you virtually at The 2021 TCT Meetings of ASTCT and CIBMTR Digital Experience or throughout the year, and we look forward to seeing you in-person in 2022!

About the BMT CTN

The CIBMTR shares administration of the BMT CTN Data and Coordinating Center with NMDP/Be The Match and The Emmes Company. Together, these three organizations support all BMT CTN activities. 

To receive up-to-date information about BMT CTN studies, meetings, and news: 

Facebook.gif Like us on Facebook: facebook.com/BMTCTN
Twitter.gif Follow us on Twitter: twitter.com/BMTCTN (@BMTCTN)

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CIBMTR Survey Research Group: PRO Survey

By Deborah Mattila

In August, the CIBMTR Survey Research Group launched patient outreach for the Protocol for Collection of Patient Reported Outcomes (PRO) Data. This protocol allows the CIBMTR to contact patients to ask them to complete PRO surveys: Starting prior to transplant or other cellular therapy, then at day 100, day 180, day 365, and annually thereafter. The data the CIBMTR collects can be merged with the patient's clinical data in the CIBMTR database to support studies, used in future trials, used by NMDP and the Medical College of Wisconsin to better understand long-term effects of HCT/CAR-T, and- in the future - shared back to the patient and their providers. 

As of October 29, the Survey Research Group enrolled and collected baseline (prior to conditioning therapy) surveys, on paper and electronically, from 5 transplant patients. In addition to being an important milestone for the protocol, this represents the CIBMTR's first successful collection of centralized baseline (pre-HCT) PRO data, made possible by the early collection of patient contact details. The CIBMTR typically relies on sites to collect baseline PROs, which is burdensome for the site and difficult to track, so this represents a great step forward.

The Protocol for Collection of Patient Reported Outcomes (PRO) Data is coordinated entirely through the CIBMTR. Centers do not actively participate in the research and do not submit the protocol to their IRB. The Survey Research Group currently approaches adult patients from three centers and plan to expand to patients from additional centers, pediatric patients, and patients who speak Spanish in 2021.

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Health Services Research

By Jaime Preussler, MS; Christa Meyer, MS; Lih-Wen Mau, PhD, MPH; Tatenda Mupfudze, PhD

Between Oct. 1, 2019, and Sept. 30, 2020, the Health Services Research team worked on the design, analysis, and / or dissemination of more than 20 studies. The team published six manuscripts in peer-reviewed journals and presented five abstracts at local and national conferences.

In the coming months, the team will analyze and disseminate the results of current studies. The team is developing multiple projects to help increase access to cellular therapies and improve patient outcomes. Highlights of a few studies include:

  • A cross-sectional survey of patients at 3-12 months post-transplant to examine the experience, knowledge, and perception of palliative care among transplant recipients. Health Services Research Program investigators are conducting this study in partnership with members of the ASTCT Palliative and Supportive Care Special Interest Group.
  • Using CMS data to examine:
    • Trends in access to and utilization of transplant among patients with AML in the Medicare and Medicaid populations
    • Prevalence of clinical complications and health utilization among patients with sickle cell disease enrolled in Medicaid who have not received a transplant

For more information about the Health Services Research Program, visit the Health Services Research webpage or email HSRrequests@nmdp.org.

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COVID-19 Tool Applied for Transplant Success

By Stephanie Fingerson

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This summer, Stephanie Fingerson, with the help of Pradeep Bashyal, both from the CIBMTR Bioinformatics Research team, developed a tool to help the NMDP/Be The Match donor center workup specialists collate some of the data needed to assess COVID-19 infection risks for donors with fresh products to be collected within the US for patient transplants. In September, the tool was released to external partners at donor centers to allow a wider audience to utilize the tool. The wider distribution has resulted in time savings and increased confidence in assessments of COVID-19 risks.

The tool (seen in screenshots shown above) maps COVID-19 statistics for counties of a selected state based on daily data from public sources. It also contains information on the location of collection centers and apheresis centers along with the current status of COVID-19 protocols required at these centers prior to collection. Users can use this tool to assess the COVID-19 risk level in a donor's home county as well as the county of nearby donor centers, by entering either a state or zip code. This allows users to view a map of the selected state with counties color-coded by COVID-19 infection level. Available information includes the total number of cases per 100,000 population and the average increase per 100,000 population over the past seven days. Hovering over counties or apheresis centers / collection centers offers additional details of infection levels or COVID-19 testing protocol.

The tool is particularly useful when fresh product infusion is planned and the patient will start their preparative regimen before the donation is collected because the tool can advise a transplant center if there is an increased risk of postponement due to COVID-19. This tool also provides information for the assessment of operational cryopreservation needs during this period of COVID-19 infection risk, helping transplant providers make informed decisions to provide the best transplant outcomes for our patients.

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Cellular Therapy Accrual and Forum

By Carlos Litovich, MPH

In September, the CIBMTR announced the completion of enrollment in the Yescarta® long-term post-marketing safety – 2 years ahead of schedule. The collaboration between the CIBMTR and Kite, a Gilead company, resulted in a long-term follow-up study that began in 2018. The first part of the study, enrollment, is complete. Now the focus is collecting 15 years of follow-up information from Yescarta recipients.

With the long-term follow-up study accrual goal met, the CIBMTR's CIDR will continue to expand the Cellular Therapy Registry launched in 2016. In addition to Yescarta recipients, the CIBMTR will collect data for patients treated with cellular therapy products both currently FDA-approved and in the future. This registry has already become a valuable resource for the community.

The second post-approval study of Kymriah® recipients (for treatment of acute lymphoblastic leukemia and non-Hodgkin lymphoma) is also accruing well, having reached 1,000 patients out of the 2,500 target accrual. The collaboration with Novartis resulted in the CIDR's first publication of CAR T-cell results, which is currently in press at Blood Advances. This report includes more than 400 recipients of CAR-T cells and demonstrates that real-world results are similar to previous observations in clinical trials, a great testament to the CIBMTR's data quality.

6th Annual Cellular Therapy Virtual Forum: Preparation for the annual forum is nearly complete. The packed agenda includes CAR-T toxicity, long-term follow-up for gene therapies, real-world data experience, and much more. The full day of interactive discussions promises to be yet another great forum for the community to share progress towards our collective mission of improving outcomes of cellular therapy recipients through research.

In addition, more than 200 participants have already registered for the Cellular Therapy Data Manager's Virtual Meeting, which is scheduled for November 1. Topics include registry and audit updates, center perspectives, and reporting tips. 

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New Data Manager Virtual Onboarding Recap

By Eileen Tuschl, DNP, ACNS-BC, APNP

Over the years, the CIBMTR has received many requests to provide new data manager onboarding. This past February, we offered our first in-person new data manager onboarding class at the TCT Meetings of ASTCT and CIBMTR. New Data Manager Onboarding is offered in-person every six months (February and August).

Due to the COVID-19 pandemic and travel restrictions, CIBMTR Data Operations could not offer an in-person class in August 2020. Instead, we offered our first New Data Manager Onboarding class VIRTUALLY via WebEx Trainings over seven days throughout September 2020 for two separate classes. The virtual classes included interactive training in our FormsNet3 training environment along with topics pertinent to new data managers for submitting quality data. A total of 50 new data managers were successfully onboarded. Topics included resources for data managers, introduction to the CIBMTR Portal, forms journey, continuous process improvement / consecutive transplant audit, center volumes data report / transplant center specific analysis / FormsNet queries, and a guide to the audit process.

Our next class is scheduled for February 2021 in conjunction with The 2021 TCT Meetings of ASTCT and CIBMTR Digital Experience. Limited to 35 participants, registration will open in November 2020.

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The CIBMTR is pioneering the automation of transmitting electronic medical record data from its research network partners to its outcomes registry. There isn't an exact roadmap to follow—this has never been done before. Bringing data together in a timely manner accelerates research to reveal new insights and transcend scientific frontiers. By treating entrusted data as an asset and investing in realizing its full value, the CIBMTR will promote breakthroughs to make a more successful patient journey.

Pilot testing a prototype

The CIBMTR used a web-based model of data collection with an extensive library of forms completed at intervals during a transplant patient's lifespan. Under the new model, the team has enabled research network partners to collect and send data from their source data systems efficiently and securely. This new model, using a prototyped set of solutions, is both future-proof and sustainable because it meets the data where it resides and allows data to become interoperable.

The CIBMTR moved quickly to design and test the prototype within a pilot. Within six months, four transplant centers completed the pilot. The results are in, and it worked! Not only does the new model help accelerate research through timely data reporting, but pilot centers also reported that reducing data entry requirements should provide cost-savings through efficiencies gained under the new model. This perceived value has the potential to allow scarce healthcare resources to redirect back into patient care.

More information about the pilot program is available in the CIBMTR's recent press release.

A team effort

Thank you to the transplant centers who submitted data to the CIBMTR under this new model:

  • Children's Hospital of Colorado
  • Moffitt Cancer Center
  • Oregon Health & Science University / Knight Cancer Institute
  • Sarah Cannon Research Institute
  • The Ohio State University

Through collaboration and determination, key learnings from the pilot will pave the future for a new era of clinical registry reporting, and the ability to scale this to the CIBMTR network quickly and efficiently.

If you are interested in learning more about this work, and how your center may become involved, please contact DT@nmdp.org

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In early November, the CIBMTR will launch an upgrade to the DBtC (Data Back to Centers) application - available on CIBMTR Portal - that includes more data and new features. DBtC is part of the suite of CIBMTR applications that provides self-service, on-demand data, and analytics to centers that submit data to the CIBMTR. For the first time, enhancements to DBtC will enable centers that submit CAR-T data to the CIBMTR to visualize CAR-T information AND HCT information within the application in the following tabs:

  • Patient demographics and counts
  • Diseases indications (for therapy)
  • Outcomes (cytokine release syndrome and neurotoxicity)

Improvements to the user interface maximize the available real estate and make use of mega filters to toggle between CAR-T and HCT data. Additionally, the CIBMTR will also provide centers with a REMS (risk evaluation and mitigation strategies) extract to support their reporting needs in meeting the requirements for commercial CAR-T products. Center users will also be able to securely download more than 8,000 CAR-T data points in common file formats for their operational and analytical needs in the same way they do for HCT data. 

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Sharing Research in Plain Language

By Jennifer Motl

These four new plain-language summaries may help your patients:

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People with memory problems need support after transplant

In older adults, memory problems may be linked to health after BMT

Read more: 1-page or accessible version


Summary 2.jpg

Guidelines needed for returning to work after transplant

87% of transplant centers say return-to-work programs would help patients

Read more: 1-page or accessible version 

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Blood and marrow transplant helps treat myelofibrosis

BMT may help more people with myelofibrosis than previously known

Read more: 1-page or accessible version

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Finding blood and marrow transplant donors for everyone

Haploidentical donors slightly better than cord blood in some cases

Read more: 1-page or accessible version

On the Study Summaries for Patients webpage, you will find two versions of new summaries from now on: A 1-page, colorful version arranged by our graphic designer, and an accessible version, formatted with larger print. The accessible summaries also have hidden formatting that allows people with disabilities, who use screen readers, to listen to the summaries. The text is the same in both versions; only the format is different.

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Additional Research Datasets Available for Secondary Analysis

By Liz Siepmann

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In accordance with the NIH Data Sharing Policy and NCI Cancer MoonshotSM Public Access and Data Sharing Policy, the CIBMTR is making publication analysis datasets publicly available on the CIBMTR Research Datasets for Secondary Analysis webpage.

These publication analysis datasets are freely available to the public for secondary analysis. While providing these data, the CIBMTR is committed to safeguarding the privacy of participants and protecting confidential and proprietary data.

NEW datasets are now available online.

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Our Supporters

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; U24CA233032 from the NCI; OT3HL147741, and U01HL128568 from the NHLBI; HHSH250201700006C, 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, R01AI128775, R01HL126589, R01HL129472, R01HL130388, R01HL131731, U01AI069197, U01AI126612, and BARDA. Support is also provided by Be the Match Foundation, Boston Children's Hospital, Dana Farber, St. Baldrick's Foundation, Stanford University, the Medical College of Wisconsin the National Marrow Donor Program, and from the following commercial entities: AbbVie; Actinium Pharmaceuticals, Inc.; Adaptive Biotechnologies; Adienne SA; Allovir, Inc.; Amgen Inc.; Angiocrine Bioscience; Astellas Pharma US; AstraZeneca; Atara Biotherapeutics, Inc.; bluebird bio, Inc.; Bristol Myers Squibb Co.; Celgene Corp.; CSL Behring; CytoSen Therapeutics, Inc.; Daiichi Sankyo Co., Ltd.; Gamida-Cell, Ltd.; Genentech Inc; HistoGenetics, Inc.; Incyte Corporation; Janssen Biotech, Inc.; Jazz Pharmaceuticals, Inc.; Johnson & Johnson; Kiadis Pharma; Kite, a Gilead Company; Kyowa Kirin; Legend Biotech; Magenta Therapeutics; Mallinckrodt LLC; Merck & Company, Inc.; Merck Sharp & Dohme Corp.; Millennium, the Takeda Oncology Co.; Miltenyi Biotec, Inc.; Novartis Pharmaceuticals Corporation; Omeros Corporation; Oncoimmune, Inc.; Orca Biosystems, Inc.; Pfizer, Inc.; Pharmacyclics, LLC; Sanofi Genzyme; Shire; Sobi, Inc.; Stemcyte; Takeda Pharma; Terumo BCT; Viracor Eurofins; Vor Bio Pharma; Xenikos BV.

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Abbreviations

Need an acronym defined? Review our list of common abbreviations.


The views expressed in this newsletter 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.

CIBMTR® is a research collaboration between the National Marrow Donor Program (NMDP)/Be The Match and Medical College of Wisconsin.










Last Updated: 1/26/2021 11:34 AM
CIBMTR