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By Robert Soiffer, MD
Understanding and manipulating donor immune responses has been the cornerstone of translational research in allogeneic HCT for nearly half a century. Through analysis of human samples and by developing experimental models, investigators have tried to link elements of immunogenetics, donor graft composition, proteomics, tumor genomics, and immune reconstitution in the hopes of predicting who will develop the often unpredictable and devastating consequences of GVHD, microbial susceptibility, and inadequate control of the underlying malignancy. We, as a community, have largely relied on analysis of blood or graft cellular components to arrive at some predictive associations, many of which have prompted interventional strategies that, in some circumstances, have been successful in addressing these life-threatening complications. To do so, we have frequently banded together to pool samples of cells and plasma from multiple centers to arrive at definitive correlations, which would be largely impossible from single center analyses. By leveraging its comprehensive and well annotated clinical database, the CIBMTR has played a critical role in these efforts.
Historically, much of our attention has focused on correlating donor cell immune reconstitution with transplant outcomes and much less on host factors that might influence immune recovery and function. However, in the past 5 years, the availability of high-throughput sequencing technology for microbiome characterization has led to convincing data from single centers correlating perturbations in the gut microbiome with GVHD, tumor relapse, and transplant survival. These observations may be startling for some, but those of us who are AARP members remember data from the 1970s that demonstrated that mice undergoing transplant in germ-free environments experienced less GVHD and better survival. This led to the use of protective environments with laminar air flow rooms, low bacteria diets, gut decontamination, and assiduous skin cleaning. The goal of these interventions was not only to reduce infectious complications but also to reduce microbial initiated inflammatory responses resulting in GVHD. Many of these precautions have been abandoned over the years because small studies supporting their use yielded conflicting results. However, most of us have witnessed clinical scenarios where infectious episodes have appeared to trigger GVHD in patients.
The impact of the microbiome on health and disease reaches far beyond HCT with correlations reported in multiple medical conditions. The development of powerful new tools such as high-throughput molecular methods including 16S ribosomal RNA gene sequencing, metabolomics, and shotgun metagenomic sequencing have opened the door for comprehensive investigation. The integrative Human Microbiome Project (iHMP) from the NIH focuses on creating integrated datasets of multiple biological properties from both the microbiome and the host over time in specific microbiome-associated diseases, specifically inflammatory bowel disease, Type 2 diabetes, and pregnancy.
There is probably no clinical scenario where shifts in the microbiome are so dramatic and likely to impact an inflammatory milieu as in HCT. Our patients receive high dose chemotherapy or radiotherapy that dramatically alters their ability to eat and disrupts mucosal barriers promoting microbial translocation. They are also exposed to both prophylactic and therapeutic antibiotics altering gut flora and immune suppressive medications compromising immune competence. Given that the risk / benefit divide is uncomfortably narrow in transplantation, it is imperative that we accelerate our understanding of the impact of shifts in the microbiome as expeditiously as possible.
To accomplish this task will take an extensive, coordinated effort. The variability in dietary, environmental, conditioning, GVHD prophylactic, and antibiotic-prescribing practices creates quite a challenge as do inconsistences of antibiotic- and infection-reporting. Moreover, uniformity of stool collection techniques, storage, and analysis need to be established. Several groups-including teams from New York, Stanford, Houston, Regensburg, Boston, Seattle, and elsewhere - are trying to spearhead this effort, and the CIBMTR should be poised to assist. To accomplish our goals of truly understanding how diet, antibiotics, chemotherapy, immune suppression, and donor / host genetic polymorphisms impact the microbiome - and, in turn, how the microbiome influences immune reconstitution and transplant outcomes - will undoubtedly be a resource-intensive undertaking. It is time to move beyond the seemingly unavoidable junior high school commentary about stool and think creatively how to marshal the support to create such a vibrant, comprehensive annotated sample repository and get going.
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2018 BMT Tandem Meetings
The BMT Tandem Meetings - the combined annual meetings of the CIBMTR and ASBMT - are North America’s largest international gathering of BMT clinicians and investigators, laboratory technicians, advanced practice professionals, transplant nurses, pharmacists, administrators, and clinical research associates since 1999.
More than 3,300 leading worldwide authorities will convene in Salt Lake City, Utah, to present the latest developments in blood and marrow transplantation at the Salt Palace Convention Center February 21-25.
More than 700 abstracts from more than 30 countries were submitted to this year’s meeting. We invite you to join us for the Best Oral Abstract Session on Friday, February 23, in Hall C, and on Sunday, February 25, as we close the meeting with Late Breaking Abstracts.
In addition to an outstanding scientific program, the 2018 meetings offer peripheral sessions for BMT pharmacists, BMT center administrators, coordinators, investigators, medical directors, clinical research professionals / data managers, transplant nurses, and advanced practice professionals. Along with state-of-the-art educational offerings, industry-supported satellite sessions and product theaters will broaden the spectrum of presentations.
Please join us after the Best Abstracts Session on Friday afternoon as the CIBMTR Distinguished Service Award is presented to Mahmoud D. Aljurf, MD, MPH. This award is presented to Dr. Aljurf for his service and commitment to the CIBMTR and its missions. Following the awards on Friday, we invite you to attend the Mortimer M. Bortin Lecture, presented by Eliane Gluckman, MD, PhD, FRCP and the E. Donnall Thomas Lecture, presented by Robert S. Negrin, MD.
Visit the 2018 BMT Tandem Meetings webpage to create your own personal agenda, register and view additional details. As of early January, more than 2,400 attendees were registered. On-site registration rates went into effect on January 24. After registering, take advantage of special conference guest room rates at a wide variety of hotels within the BMT Tandem room block.
Remember to reserve your ticket to the BMT Tandem Reception on Saturday, February 24, at the Salt Palace Convention Center, South Foyer.
Tandem Goes Mobile!Attendees may now download the official BMT Tandem Meetings app for quick and easy access to the most current version of the meeting schedule, attendee list, venue information and more! Watch for additional details in your email. The app is free for all attendees and with wi-fi available throughout all BMT Tandem meeting rooms, users can:
Questions regarding support opportunities at the 2018 BMT Tandem Meetings may be directed to Sherry Fisher, Director of Advancement for the CIBMTR. For general information, email email@example.com.
We look forward to seeing you in Salt Lake City!
2017 CIBMTR Annual Report
We recently published the CIBMTR 2017 Annual Report. This report focuses on information most important to transplant center personnel and other partners. We explain who we are, what we do, how we share knowledge, how we collect and manage data, and what we will do next. Review the electronic version to access links directly, or pick up a hard copy at the CIBMTR booth at the BMT Tandem Meetings.
Consumer Advocacy Representatives:
GVHD is the most critical complication of allogeneic HCT, and its occurrence prevents favorable outcomes in a large proportion of affected patients. GVHD is an entirely iatrogenic complication of allogeneic HCT, and its prevention and treatment are of paramount importance to the transplantation community. In the last few years, increased attention has been paid to the prevention and treatment of GVHD as alternative and mismatched donors have been increasingly used in transplantation and as novel immunosuppressive agents have been developed for the treatment of the autoimmune and rheumatologic conditions. The GVHD Working Committee examines both acute and chronic GVHD outcomes across all diseases treated by allogeneic HCT.
Under the committee leadership (listed above), the GVHD Working Committee has focused on:
The GVHD Working Committee has 11 ongoing studies with plans to complete at least 3 studies each academic year, making it one of the most productive committees. This committee benefits from broad enrollment to the CIBMTR Research Database. The number of allogeneic HCTs in 2001-2016 total >44,000 for leukemic diseases (AML, ALL, MDS, CML, and other leukemia) and >18,000 for non-leukemia malignancies.
The GVHD Working Committee is always seeking interesting and novel ideas for study as well as encouraging the involvement of junior investigators and those wanting to break into the field of BMT and outcomes research. Join the GVHD Working Committee for their annual in-person meeting during the BMT Tandem Meetings on Friday, Feburary 23, 12:15 to 2:15 p.m. in the Salt Palace Convention Center, Room 355 BC.
View planned, in-progress, and completed studies and publications on the GVHD Working Committee webpage.
The Lymphoma Working Committee, one of the first established within the CIBMTR, focuses on cellular therapy for both Hodgkin lymphoma (HL) and NHL patients and has conducted numerous studies addressing a wide range of issues in the field of HCT for patients with these diseases. Although the number of autologous and allogeneic HCTs have been steadily increasing over time for both HL and NHL, the role and optimal timing of HCT is evolving in light of ever-increasing numbers of new pharmacologic and immunologic therapies. In addition, advances in molecular profiling / subtyping and the discovery of new biologic risk factors, combined with the increasing utilization of metabolic imaging in lymphomas, have led to the identification of multiple subsets and heterogeneity in lymphoma in general. Even within specific lymphoma subtypes, there is substantial heterogeneity, which requires continuous re-evaluation of the role and timing of HCT for these patients.
Since 2008, the disease-specific research-level forms have collected basic PET scan information, such as whether a PET scan was performed or not and whether it was positive at any site prior to the start of the conditioning regimen. Since 2013, the updated forms collect additional PET information, such as whether there was nodal versus organ involvement, and not just pre-transplant but also at the time of transformation. In 2018, an updated version of lymphoma disease-specific forms will be implemented to capture molecular testing information, such as whether certain chromosomal translocations were identified in the lymphoma, and other molecular subtyping information, such as germinal center versus non-germinal center “cell of origin” for diffuse large B-cell lymphoma (DLBCL). This additional information will allow the Lymphoma Working Committee to conduct more up-to-date and clinically relevant analyses in the future. At the same time, the increasing use of new transplantation and cellular therapy strategies (e.g. the use of haploidentical donors for allogeneic HCT and the use of CAR T cell therapies) will result in additional important data for the Lymphoma Working Committee to capture and analyze.
Thanks to the considerable number of lymphoma patients treated with HCT whose data are in the CIBMTR Research Database, the Lymphoma Working Committee is able to provide information with the capacity to change clinical practice in many transplant related issues.
The Lymphoma Working Committee has been extremely active over the last few years, in large part due to the extensive data available in the CIBMTR Research Database. The number of transplants for lymphoma added to the Research Database from 2000 through 2017 are listed in the table below. During the annual committee meeting at the 2017 BMT Tandem Meetings, 8 new proposals were presented, and 3 were approved to be further developed and analyzed. In 2016, 8 proposals were presented, and 3 studies were approved. Join the Lymphoma Working Committee at their annual in-person meeting at the 2018 BMT Tandem Meetings on Wednesday, February 21, 2:45 - 4:45 p.m. in the Salt Palace Convention Center, Room 355 E.
The Lymphoma Working Committee was also quite productive with presentations and publications in 2017. Committee investigators presented five oral abstracts at national and international conferences, including one at the ASCO Annual Meeting and three at the BMT Tandem Meetings. They published seven manuscripts in peer-reviewed journals, including Journal of Clinical Oncology, Cancer, and Biology of Blood and Marrow Transplantation. There is also an important ongoing Clinical Practice Guideline collaboration between CIBMTR, EBMT, and ASBMT for post-autologous HCT maintenance strategies as well as regarding conditioning regimens for allogeneic HCT in lymphoma.
Several of the Lymphoma Working Committee publications in recent years are of particularly high impact, including the demonstration that chemosensitivity to salvage regimens may overcome the adverse prognosis associated with early relapse in DLBCL patients undergoing autologous HCT (Hamadani et al, Biol Blood Marrow Transpl, 2013) and two studies indicating comparable outcomes - in terms of treatment-related mortality, relapse / progression, and overall survival - using haploidentical donors versus matched sibling donors (Ghosh et al, J Clin Onc, 2016) or matched unrelated donors (Kanate et al, Blood, 2016).
Going forward, there are a number of clinically relevant questions yet to be addressed that can only be studied in a large registry dataset. Examples include the role of HCT in rare types of lymphomas, comparative analyses between “experimental” stem cell sources and more “standard” sources, prognostic factors modifying the long-term outcome of HCT in different histologies and disease situations, and comparisons between allogeneic and autologous HCT in specific clinical scenarios. The Lymphoma Working Committee is also in the position to be a major player in joint studies with other scientific transplant societies, such as the EBMT.
View planned, in-progress, and completed studies and publications on the Lymphoma Working Committee webpage.
Enter your answer online. If you answer correctly, you will be entered into a drawing to win a CIBMTR prize.
Left top corner to right: Tom Moerke, Tim Skowronski, Josh Gier, Carolina Espinoza, Tad Degen, Charles Zhang, Xioaolan Zhang, Barbara Liu, Erik Bergman, Tian Hongu, Mita Desai; Not picutred: Paul Gengler and Angela Kummerow
The CIBMTR Information Technology (CIT) Team includes >60 personnel on the Minneapolis and Milwaukee campuses. CIT supports a diversified continuum of IT and informatics solutions that serve the CIBMTR and its stakeholders. Both campuses share the same, unified commitment to the CIBMTR mission and work together in an integrated fashion to achieve strategic and operational goals. CIT is organized according to specialization, expertise, and the capabilities required of the products and services supported. That support extends along the life cycle of data from capture to validation, extraction, and use in research.
Three teams of CIT professionals are dedicated to enhance, maintain, and support CIBMTR electronic data capture solutions, including FormsNet and AGNIS (A Growable Network Information System). The primary channel for centers to contribute their data to CIBMTR is FormsNet. Now in its third generation, FormsNet is regularly enhanced, requiring coordination not only within CIT or even CIBMTR but throughout the scientific community. Metadata analysts uphold the CIBMTR commitment to facilitate data interoperability by curating common data elements and linking these to industry standard terms. Business analysts, software developers, and other IT professionals identify and transform functional requirements into system features to create new forms, validate user responses within acceptable ranges, hide or expose questions based on user response, make other forms come due, and much more. Since form changes in AGNIS follow closely on the heels of those implemented in FormsNet, the AGNIS team is engaged in very similar activities, with the added challenge of facilitating system to system data exchange.
Another group of IT specialists maintain and enhance the process by which data is extracted from our data capture systems and loaded into our analytical systems. This process, known as data extraction, transformation, and load (ETL), is integral in moving data between systems in a controlled fashion. It also is essential for validating data for consistency, completeness, and accuracy within and across data capture forms. CIT programmers, business systems analysts, and data analysts work closely with a cross-functional Data Quality Team and with CIBMTR Scientific Directors to embed in logic the collective knowledge of the scientific community and to continuously measure the quality of data against this logic.
Data that pass these quality criteria are loaded into the CIBMTR Research Database, which is used for research and sharing data. The Research Database team consists of database analysts and a database administrator, all with extensive experience. They harmonize changes to the Research Database resulting from form revisions and continuous improvements. CIT also loads data into the CIBMTR Integrated Data Warehouse (IDW). The IDW touches virtually every facet of CIBMTR, and CIT holds a key role in its design, development, and implementation. Data architects, business systems analysts, and programmers work side by side with CIBMTR Scientific Directors, statisticians, and other subject matter experts to build and enhance the IDW.
CIT team members who focus on the CIBMTR data sharing mission extract data from CIBMTR analytical systems and present these data to meet stakeholder needs. To do so, CIT team members maintain and enhance data extracts, which statisticians use to create study data sets. These data are also shared with centers and other stakeholders through applications in Qlikview and applications custom-built to meet the community’s needs. Each of these applications were designed to fulfill specific data and information purposes. CIBMTR gathered stakeholder input in the design and update of these applications via in-person site visits and annual meetings and forums.
Throughout the data lifecycle, CIT project managers and AGILE ScrumMasters coordinate, remove obstacles, allocate resources to fulfill demand, manage risk, and escalate issues to leadership. Programmers and system administrators maintain and enhance the CIBMTR web presence and its interfaces with other core systems. Information security personnel ensure that CIBMTR maintains the most current practices and systems that provide data privacy and cybersecurity.
CIT professionals enhance and maintain operational systems that enable the CIBMTR to function on a daily basis. They are the backbone that allows centers to submit and retrieve high-quality data as efficiently as possible. Their work allows statisticians to create accurate and complete data sets that drive practice-changing research. They ensure CIBMTR data are secure. They support every facet of the CIBMTR organization.
In the Maximizing BMT CTN Biorepository Samples session, Steven Spellman, Director of Immunobiology & Observational Research, NMDP/Be The Match, will share what samples and resources are available to interested investigators. Dr. Shernan Holtan, University of Minnesota Blood and Marrow Transplant Program, will provide results of her ancillary studies conducted using BMT CTN samples. There will also be a BMT CTN 1506 (AML Maintenance Therapy) study update presented by Dr. Yi-Bin Chen, Massachusetts General Hospital. We hope you can join us!
The BMT CTN Coordinators Meeting will be held Wednesday, February 21, 7:30 am – 3:00 pm MT, in Room 251 DEF. The meeting will cover BMT CTN processes and study overviews, and it will feature presentations from several BMT CTN Investigators. We hope to see all the BMT CTN study coordinators there.
Don’t miss the BMT CTN 1203 (PROGRESS I; GVHD Prophylaxis) study results presented in the Late Breaking Abstracts session on Sunday, February 25, at 12:30 pm MT, presented by Javier Bolaños-Meade, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: Novel Approaches for Graft-Versus-Host Disease (GvHD) Prophylaxis: Primary Results of Progress I Multicenter Trial of Matched Allogeneic Hematopoietic Cell Transplantation (alloHCT) Using Reduced Intensity Conditioning (RIC) BMT CTN 1203.
Also, please stop by the BMT CTN booth. BMT CTN Investigators and Data and Coordinating Center staff will be there during breaks to answer your questions and provide ideas for how your center can get involved.
About the BMT CTN
The CIBMTR shares administration of the BMT CTN Data and Coordinating Center with National Marrow Donor Program/Be The Match® and The Emmes Corporation®. Together, these three organizations support all BMT CTN activities.
To get up-to-date information about BMT CTN studies, meetings, and news:facebook.com/bmtctntwitter.com/bmtctn (@BMTCTN)
Electronic Patient Reported Outcomes
By Erin Leckrone
Within RCI BMT, the Survey Research Group operates as a stand-alone team to assist researchers in developing and conducting research involving questionnaires, direct subject interviews and patient-reported outcomes. The group handles collecting high quality, scientifically valid data from donors, patients and their families. The Survey Research Group currently utilizes standardized and semi-structured telephone interviews as well as self-administered questionnaires.
In 2017, the CIBMTR began planning and developing an electronic Patient Reported Outcomes (ePRO) system. Within an ePRO, patients can access and complete the questionnaires from a link sent by SRG. The system integrates Qualtrics as a patient-facing interface with Salesforce as the client relationship management system. It delivers PROMIS (Patient-Reported Outcomes Measurement Information System) measures using computer adaptive testing (CAT) technology. PROMIS are person-centered measures that evaluate physical, mental, and social health and are supported by a NIH initiative. The CAT technology presents a respondent with items from an item bank. As a patient completes the initial question in an item bank, the CAT algorithm selects only those next items that sharpen estimation of the patient’s score in the domain. This technology decreases respondent burden as patients only see questions that are relevant to them. During 2017, the CIBMTR selected vendors, secured internal resources, and reviewed the system design with the Architecture Review Board, information security team, and enterprise project management office. The team is on track to complete the initial build phase of the ePRO system in time to enroll patients in a pilot study in spring 2018.
HCT Workforce Capacity
2018 BMT Tandem Meeting Activities
In early Feburary, physicians and search coordinators will receive an invitation to participate in the Unrelated Donor Search and Selection Survey.
The goals of this research survey are to better understand standard practices for unrelated donor searches at transplant centers in the US and to identify potential solutions to facilitate urgent transplants for eligible patients. Your responses will inform services and programs offered to centers by NMDP/Be The Match.This online survey will take about 15 minutes to complete. Our goal is to receive an 80% response rate.Your participation is voluntary, and your responses are confidential.
To thank you for your time, you may elect to be entered in a drawing to win a $100 Visa gift card. One hundred Visa gift cards will be dsitributed.Check your email for this survey as it will be closing on March 12.
For questions about the study, contact Tatenda Mupfudze, PhD, firstname.lastname@example.org or (763) 406-5128.
We appreciate your consideration of this important study.
Sincerely,Joseph Pidala, MD, PhDChair, NMDP/Be The Match Histocompatibility Advisory GroupH. Lee Moffitt Cancer Center & Research Institute
Presentations were met with great enthusiasm from the participants with talk of convening another workshop in 2019.
The CIBMTR Audit Team launched a new SharePoint website that allows transplant centers to easily access their CIBMTR audit documents.
To access the CIBMTR Portal ("Portal"), follow the instructions below. Please note: Only Medical Directors and Primary Contacts listed in Salesforce are allowed access to audit data through the Portal. For others who desire access, please reach out to your center's Primary Contact.
Instructions for Gaining Portal Access:
From this point, you may view your chosen document online, download it, or print it.
For questions or issues related to Portal access, contact email@example.com.
For questions related to audit folder contents (e.g. missing documents, etc.), contact Jenna Umar, Clinical Trials Assistant, at firstname.lastname@example.org.
By Jessica Gillis-Smith, MPH
Five new patient summaries of CIBMTR publication were recently posted on the CIBMTR Patient Resources webpage.
Summaries are created through a collaborative process involving CIBMTR Consumer Advocacy Committee members; CIBMTR and NMDP/Be The Match Medical Writers, Communications Specialists, and Patient Education Specialists; and CIBMTR Scientific Directors. Developing these summaries is one of the main initiatives of the Consumer Advocacy Committee.
The Consumer Advocacy Committee was created in 2005 as a subcommittee of the Advisory Committee to communicate CIBMTR research results and data to the non-medical community and to provide patient and donor perspectives during the development of the CIBMTR research agenda. Many members have personal experience as a donor, recipient, or family member.
Our SupportersThe CIBMTR is supported by Public Health Service Grant/Cooperative Agreement 5U24CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 4U10HL069294 from NHLBI and NCI; a contract HHSH25020170006C with Health Resources and Services Administration (HRSA/DHHS); two Grants N00014-17-1-2388 and N0014-17-1-2850 from the Office of Naval Research; and grants from our corporate and private contributors.