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February 2016 Newsletter

Volume 22, Issue 1

Perspectives

By Paul Martin, MDDetta1.jpg

Some recent studies of the BMT CTN have used a “Pick the Winner” design to select approaches for further investigation. Historically, the CIBMTR has shown an uncanny ability to pick many winners, one of whom is now at the brink of retirement: D’Etta Waldoch Snyder, CMP, the person who deserves much of the credit for the remarkable success of the annual BMT Tandem Meetings.

Dr. Mortimer Bortin, founder of the IBMTR, hired D’Etta as a secretary in 1981 after she had worked for three years as a medical secretary at Mount Sinai Hospital in downtown Milwaukee. Within a year, she was promoted to Data Coordinator. In this role, D’Etta often taught others about the Database, including the current Chief Scientific Director, Mary Horowitz. In 1991, D’Etta was promoted to Database Manager. During her first decade working with the Database, the total number of patients registered with the IBMTR increased 15-fold from approximately 2,600 to nearly 39,000.

D’Etta’s major contributions to the CIBMTR have come from her outstanding work as Program Manager responsible for organizing our national meetings since the mid-1990’s. The initial meeting sponsored by the IBMTR in 1993 was a one-day conference involving 200 participants who were mostly physicians. D’Etta managed the growth of the annual meeting to its present configuration as a five-day conference sponsored in collaboration with the ASBMT and involving more than 3,000 participants and 750 abstracts. Participants now include not only physicians but also nurses, pharmacists, data coordinators and managers, and administrators. The BMT Tandem Meetings represent the largest North American gathering of worldwide experts in patient care, clinical investigation, and laboratory research related to HCT.

To me, the logistics of organizing the BMT Tandem Meetings are almost unimaginably complex since the task touches not only on mapping the scientific programs, speakers, abstracts and Working Committee Meetings but also on selecting the venue; contracting for audiovisual, housing, food, and beverage services; and managing registration, continuing medical education compliance, and credit. Throughout all this, D’Etta has maintained strong working partnerships with the ASBMT and pharmaceutical sponsors. The work year after year has been consistently accomplished within budget and on time, and on top of everything, she has made it all look effortless and even enjoyable.

I can easily guess what Dr. Bortin recognized when he hired D’Etta: a deep sense of commitment; an ability to learn and master new work roles; outstanding interpersonal skills; great problem-solving abilities, resilience, and adaptability; and a capacity to acquire the skills needed to manage a diverse and complex organizational team.

So here we are, 35 years later, filled with gratitude for D’Etta’s many contributions and perhaps asking ourselves, “How is the CIBMTR ever going to survive without D’Etta?” I have no worries in this regard. From knowing D’Etta, I would venture that she has spent much of the past several years in careful succession planning to prepare the CIBMTR for her transition into retirement. Also, she will continue to provide guidance in a part-time capacity for a while.

We can be confident that the BMT Tandem Meetings will continue to grow and prosper by following and extending the trail that D’Etta has blazed across her years of outstanding service to the CIBMTR — a career most deserving of personal satisfaction and pride. On behalf of the CIBMTR, I offer D’Etta heartfelt congratulations and best wishes for a long and enjoyable retirement. For the CIBMTR, may we always enjoy such success in picking winners!

Acute Leukemia Working Committee


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H Jean Khoury,
MD,
Chair


Acute leukemia remains the most common indication for allogeneic HCT. With transplant practice undergoing dramatic changes, observational studies play key and complementary roles in determining trends and identifying risk factors and prognostic indicators in a fast-evolving field. The development of reduced intensity conditioning regimens, wide availability of high-resolution HLA typing, new combinations of immunosuppressive agents, and use of post-transplant cyclophosphamide for the prevention of GVHD opened the door for broad applicability of alternative donor transplants, including haploidentical donors, and the expanded use of allogeneic transplantation to older patients.

Committee Leadership

Co-Chairs:

Scientific Directors:

Statistical Director:

Statistician:

The success of the Acute Leukemia Working Committee (ALWC) derives predominantly from a strong team with collaborative input. Committee leadership works closely with committee members, data managers, and transplant groups in the US and abroad. The ALWC is responsible for developing and promoting the scientific agenda, established with the input from WC members; determining priorities in the selection of high-impact studies; and ensuring timely progress in protocol development, statistical analyses, manuscript development, and publications. This committee strives to improve quality and efficiency and is guided by the three principles established by the CIBMTR Advisory Committee: publish peer-reviewed papers of high scientific impact, complete studies within a reasonable time period, and ensure inclusiveness and fairness within the study process.

The ALWC’s recent academic activity includes one presentation at the 2015 BMT Tandem Meetings, two presentations at the 2015 ASH Annual Meeting, and six submitted / accepted manuscripts. Nine proposals were selected for presentation to the ALWC at the 2015 BMT Tandem Meetings, and 27 proposals were submitted for the 2016 BMT Tandem Meetings. These numbers are a reflection of a rapidly evolving field and a high level of interest in the rich and vast data within the CIBMTR Research Database. We hope to continue to receive more great proposals from colleagues around the world!

Number of Cases in the CIBMTR Research Database​ ​ ​
​TED-Level Data ​CRF-Level Data
AML​
     ​Autologous HCT ​5,235 ​977
     Allogeneic HCT ​39,688 ​19,260
ALL​
     Autologous HCT​ ​805 ​156
     Allogeneic HCT​ ​20,272 ​10,026

Lymphoma Working Committee


Tim_Fenske.jpg
Timothy Fenske,

​MD, MS,
Chair
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Anna Sureda,
​MD, PhD,
Chair
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Sonali Smith,
​MD,
Chair
Mehdi3.jpg
Mehdi Hamadani,
​MD,
Scientific Director
 

The Lymphoma Working Committee, one of the first established within the CIBMTR, focuses on cellular therapy for both Hodgkin’s lymphoma 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 Hodgkin’s lymphoma and NHL, HCT is facing the challenge of introducing new drugs that are potentially modifying the role, results, and optimal timing of HCT in these patients. In addition, advances in gene expression profiling, other biologic risk stratification, and the increasing utilization of metabolic imaging in lymphomas has led to the identification of multiple subsets and heterogeneity in lymphoma. The current research-level forms now capture important biologic and pathologic features as well as PET results, and they will allow more modern and detailed analyses moving forward. On the other side, the advent of new transplantation strategies, e.g. the use of haploidentical donors, has significantly increased the number of at least theoretical candidates for an allogeneic HCT.

Committee Leadership

Co-Chairs:

Scientific Director:

Statisticians:

Thanks to the significant number of lymphoma patients treated with HCT in the CIBMTR Research Database, the Lymphoma WC is able to provide information with the capacity to change clinical practice in many transplant-related issues. Current questions to be addressed within such a large registry are related to the role of HCT in rare types of lymphomas, comparative analyses between “experimental” stem cell sources and “more standard ones”, 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 WC is also in the position to be a major player in joint studies with other scientific transplant societies, such as the EBMT.

The Lymphoma WC 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 2015 are listed in the table below. During the annual committee meeting at the 2014 and 2015 BMT Tandem Meetings, 12 and 8 new proposals were presented, respectively, and 3 were approved each year to be further developed and analyzed. The Lymphoma WC was also quite productive with presentations and publications in 2015. Committee investigators presented seven oral abstracts at national and international conferences, including two at the ASH Annual Meeting and three at the BMT Tandem Meetings. They published seven manuscripts in peer-reviewed journals, including one in Blood, three in Biology of Blood and Marrow Transplantation, and three in Bone Marrow Transplantation, giving an overall impact factor of 31.45.

Number of Cases Added to the CIBMTR Research Database, 2000 - 2015​ ​ ​
​TED-Level Data ​CRF-Level Data
NHL​​
     Allogeneic HCT​ ​11,653 ​3,924
     Autologous HCT​ ​35,402 ​4,193
Hodgkin's Lymphoma​
     ​Allogeneic HCT​ ​2,900 ​472
     Autologous HCT​​ ​13,894 ​1,261

CIBMTR Trivia

CIBMTR research involves _______ major programs.

  1. 4
  2. 5
  3. 6
  4. 7

Click here to enter your answer. If you answer correctly, you will be entered into a drawing to win a CIBMTR prize!

2016 BMT Tandem Meetings on the Horizon

By Tia Houseman and D'Etta Waldoch Snyder, CMP
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The BMT Tandem Meetings - the combined annual meetings of the CIBMTR and ASBMT - are North America’s largest international gathering of blood and marrow transplant clinicians and investigators, laboratory technicians, advanced practice professionals, transplant nurses, pharmacists, administrators, and clinical research associates since 1999.

Have you registered for the 2016 BMT Tandem Meetings in Honolulu, Hawaii yet?

With February 18-22 quickly approaching, about 3,000 leading worldwide authorities will convene in Honolulu to present the latest developments in blood and marrow transplantation during the BMT Tandem Meetings at the Hawaii Convention Center.

More than 775 abstracts from 40 different countries were submitted to this year’s meeting. This is more than 100 more than the 2015 total. In addition to an outstanding scientific program, the 2016 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.
 
Scientific Program Chairs for the 2016 meetings, Corey Cutler, MD, for the CIBMTR and Pavan Reddy, MD, for ASBMT, will preside over the Best Oral Abstract Session on Saturday, February 20. Please join us after the Best Abstracts Session as the CIBMTR Distinguished Service Award is presented to Dao-Pai Lu, MD. Prof. Lu performed the first transplant in China more than 50 years ago, kept the dream of transplant alive in China, and re-established the field there in 1980. We invite you to attend the Mortimer M. Bortin Lecture, presented by Jane F. Apperly, MD, and E. Donnall Thomas Lecture, presented by Yasuo Morishima, MD, Saturday afternoon as well.
 
Visit the 2016 BMT Tandem Meetings homepage to create your own personal agenda, register, and view additional details. As of mid-January, more than 2,500 attendees were registered. 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 Tandem Reception on Sunday evening at the Royal Hawaiian Hotel on the Ocean Lawn and in the Monarch Room.
 

Tandem Goes Mobile!

You are now able to download the official BMT Tandem Meetings app for quick and easy access to the most current version of the schedule, attendee list, venue information, and more! Search for BMTTandem in your app store. Once you've downloaded the app, enter the same email address used to register for the meeting for access verification. The app is free for all attendees, and with Wi-Fi available throughout all BMT Tandem Meeting rooms, users can:
  • View and search the meeting program schedule
  • Vote / participate in interactive sessions
  • Complete Working Committee surveys
  • Search for speakers
  • Check out who is exhibiting and find their booth on a map
  • Create a personal schedule
  • Message other attendees
Questions regarding support opportunities at the 2016 BMT Tandem Meetings may be directed to Sherry Fisher at slfisher@mcw.edu.
 
For general information, please email the conference office at bmttandem@mcw.edu.
 
We look forward to seeing you in Honolulu!
 

2015 CIBMTR Annual Report

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We recently published the CIBMTR 2015 Annual Report. The new format of the report this year 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.


Meet the Recipient Data Management Team

The Recipient Data Management Team consists of 14 Clinical Research Coordinators, 5 located in Milwaukee and 9 located in Minneapolis. The Milwaukee team is led by Clinical Research Manager, Sharon Meiers, and the Minneapolis team is led by Clinical Research Recipient Data Management Supervisor, Kay Gardner.

​Milwaukee Campus

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Left to Right: Andrea Pope, Sharon Meiers, Amy Prentice, Tiffany Hunt, and Drea Benoit

Not featured: Kavita Bhavsar

 

​Minneapolis Campus

Minneapolis Campus1.jpg

Front Row (left to right): Peter Wallace, Andrea Mitsch, Alisha Mussetter, Liz Johnson

Back Row: Tina Thole, Elliott Mitchem, Christina Olson, Ally Draxler, Kristy Nutter, Kay Gardner

 
The primary focus of the Recipient Data Management Team is data quality, including continuous process improvement (CPI) and responding to questions from the network regarding recipient data collection forms. Each CRC is assigned approximately 50 transplant centers, some in the US and some outside the US.

CRCs are also responsible for ad hoc projects related to other CIBMTR activities, including the Data Back to Centers application, BMT CTN, and Portal Help Desk. Two CRCs, Amy Prentice and Liz Johnson, have a different role; they work with CIBMTR IT to enhance FormsNet and improve data collection. All of the CRCs work on a variety of committees, across teams or within their own, to improve processes and better serve their customers.

One significant accomplishment of the Recipient Data Management Team in 2015 was to move error corrections and forms review from a paper-dominant process to an electronic one. The response from data managers has been very positive. The CRCs continue to review processes to try to improve efficiency.

Regardless of the specific project the CRC is assigned to, their main responsibility is ensuring high quality data is available to support our research. Even though the CRCs on the Milwaukee and Minneapolis campuses are separated by 350 miles, they work together seamlessly and with strong team spirit.
 

Announcing the new ASBMT HCT Value and Health Economics Special Interest Group!

By Linda Burns, MD; Beth Murphy, EdD, RN; Kristen Edsall

The CIBMTR Health Services Research Program and NMDP/Be The Match Payer Policy, in conjunction with ASBMT, is excited to announce the newest ASBMT Special Interest Group (SIG) – the HCT Value and Health Economics SIG.

Recently approved by the ASBMT Executive Committee, the SIG will provide a national and international forum for exchanging ideas, developing educational initiatives, setting research agendas, conducting collaborative research, and disseminating information on topics related to health economics and the value of HCT (e.g., costs and utilization of care, cost-effectiveness and benefit analyses, patient-centered components of value, and other health economic topics).
 
Members will be required to:
  • Actively participate in SIG meetings (at least quarterly) via phone and annual in-person meeting at the BMT Tandem Meetings.
  • Contribute to educational activities (e.g., SIG-sponsored conference presentations, sessions, webinars)
  • Support the development and implementation of a research agenda to define and measure value in HCT
  • Seek and provide peer feedback on research questions, data sources, study proposals, and funding opportunities
  • Collaborate to conduct scientifically robust research to answer value-focused research questions
The SIG will have a Steering Committee with members serving two-year terms. Steering Committee members must be members of the SIG and may be re-appointed. We are pleased to announce that Richard Maziarz, MD, of the Oregon Health and Science University, was approved by the ASBMT Executive Committee to be the first Chair of the Steering Committee.
 

Mark your calendar for upcoming events:

  • Webinar: We’ll “kick off” our SIG efforts with an NMDP/Be The Match-sponsored webinar at 11:00 am CST on February 1, during which we’ll share information regarding the impact of the Affordable Care Act on transplant centers and results from the recently completed transplant center financial needs assessment.
  • Open inaugural SIG Meeting: The first SIG meeting will be held during the BMT Tandem Meetings on Friday, February 19, 6:30 – 8:30 pm in room 318A. We’re planning an interactive agenda and look forward to your feedback on projects to tackle in 2016. Everyone interested in joining the SIG is invited to attend this open meeting.
If you’d like to join the SIG, are interested in a leadership role on the Steering Committee, or have any questions, please contact Linda Burns, MD, Health Services Research Program Medical Director, at lburns2@nmdp.org or Richard Maziarz, MD, at maziarzr@ohsu.edu.
 
We look forward to an exciting collaborative effort!
 

Blood and Marrow Transplant Clinical Trials Network

By Amy Foley, MA
 
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The BMT CTN, with its 20 core and approximately 100 affiliate centers, has enrolled more than 8,500 patients since 2003. The CIBMTR shares administration of the BMT CTN Data and Coordinating Center with NMDP/Be The Match and The Emmes Corporation. Together, these three organizations support all BMT CTN activities.

The BMT CTN Steering Committee is currently under the leadership of Chair Steve Devine, MD (Ohio State University). Rick Jones, MD (Johns Hopkins) continues to serve as Vice-Chair, and Fred Appelbaum, MD (Fred Hutchinson Cancer Research Center) is now serving as Immediate Past-Chair.

See you at the 2016 BMT Tandem Meetings!

Are you an investigator wanting to get involved? The CIBMTR and BMT CTN Orientation Session will be held Saturday, February 20, 7:00 – 8:00 am HAST, in room 323B. Presenters Marcelo Pasquini, MD, MS, and Bronwen Shaw, MD, PhD, will describe specific ways to participate in both programs.

All attendees are welcome to join us at the BMT CTN Investigators Meeting showcasing upcoming and accruing studies. This year’s agenda includes BMT CTN studies on aplastic anemia, myeloma, sickle cell, CNI-free GVHD prophylaxis, and treatment for acute GVHD based on clinical and biomarkers-based risk stratification. The meeting will be held Thursday, February 18, 2:45 – 4:30 pm HAST, in 310 Theater.

The BMT CTN Coordinators Meeting will be held Thursday, February 18, in Room 311. The meeting will cover BMT CTN processes and study overviews and, as always, will feature presentations from several BMT CTN investigators. We hope to see all of the BMT CTN study coordinators there!
 
Please support your colleagues as they present their BMT CTN abstracts:
 
​Date & Time ​Session & Location ​Presenter ​Presentation Title
Thursday, Feb. 18
6:45-7:45 pm​
​Poster Session 1: Supportive Care and Nutrition

Exhibit Hall 3

R Maziarz ​BMT CTN Trials: A Rich Source for Regimen Related Toxicity Assessments in the Modern Era
Friday,
Feb. 19
4:45-6:45 pm​
​Session E: Allogeneic Transplant GVHD

313 ABC

​P Carpenter ​Prednisone (PDN) / Sirolimus (SRL) Compared to PDN / SRL / Calcineurin Inhibitor as Treatment for cGVHD: A Randomized Phase II Study from the BMT CTN
Friday,
Feb. 19
5:00-7:00 pm​
PEDS: Best Pediatric Abstracts

Ballroom B

​N Kamani ​Results of BMT CTN 0601 SCURT - a Multicenter Phase II Trial of Unrelated Donor Reduced Intensity Bone Marrow Transplantation for Children with Severe Sickle Cell Disease
​Saturday, Feb. 20 4:30-4:45 pm ​Special Invited Abstract

Exhibit Hall 3

​B Scott ​BMT CTN 0901 Randomized Trial Results (Multi-Center Study of Allogeneic Stem Cell Transplantation after High Versus Reduced Intensity Conditioning in Patients with MDS or AML)
​Sunday, Feb. 21
4:45-6:45 pm​
Session J: Allogeneic Transplant Biomarkers and Complications

Exhibit Hall 3

​L Newall ​Angiogenic Factors, Inflammation, and Outcomes in Myeloablative Allogeneic HCT: A Biomarker Analysis of GVHD Prophylaxis in BMT CTN 0402
 
And don’t forget to 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.
 

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

Implementation of Consecutive HCT Auditing

By Janet Brunner-Grady, PA-C, and Marie Matlack
 
CIBMTR Data Operations has implemented a new process to ensure reporting of all allogeneic and autologous transplants performed at US centers. For the first year, network centers have been asked to submit a list of all HCTs in consecutive order that have occurred between the dates of December 3, 2007, and December 31, 2014. In subsequent years, centers will only have to provide the previous year’s transplant information. Providing this information will allow us to confirm patients reported to the CIBMTR are representative of all patients transplanted. If a center performs but does not report autologous HCTs to the CIBMTR, they are only required to submit a list of their allogeneic HCTs.

Each year, centers will have until March 1 to submit their consecutive HCT list to their CRC. Any discrepancies between the center’s list and the data reported in FormsNet, based on the audit process, will need to be resolved by June 30. If the discrepancies are not resolved, the center will be placed in “First Warning” for the CPI trimester ending August 31.

Stem Cell Therapeutic Outcomes Database

By Carol Doleysh
 
The SCTOD is part of the US HRSA-funded CW Bill Young Cell Transplantation Program that collects data on all allogeneic HCTs performed in the US and on transplants performed elsewhere using cellular products that originated in the US. Several activities of the SCTOD, including Center Outcomes and Data Back to Centers, are highlighted below.
 

Center Outcomes

Outcomes reporting in allogeneic HCT is necessary to provide information requested by patients, insurers, and government agencies and to comply with current laws. The SCTOD contract requires the CIBMTR to conduct an analysis of one-year survival rates at each transplant center in the US annually. The report generated by the CIBMTR is meant to be useful as a quality improvement tool for transplant centers.

The 2015 Center-Specific Outcomes Report, which includes first allogeneic HCT performed between 2011 and 2013 in the US, was distributed in mid-December to Center Directors and Payors. The data was also updated on the Be The Match website.
 
In order to be included in the analysis, transplant centers were required to have at least one year of follow-up on more than 90% of related and unrelated HCT recipients. A description of the methodology used in generating this report can be found on the CIBMTR website.
 

Data Back to Centers

The CIBMTR is working to enhance the data reports available through the Data Back to Centers application on the Portal site. New features will include charts, filters, dashboards, and ad hoc reporting. The ability to download the center’s entire dataset in comma-separate value (CSV) format will remain available. A demonstration is planned during the 2016 BMT Tandem Meetings, and the CIBMTR intends to release the enhanced reports later in the year. The expanded functionality will also include the ability for centers to download their individual data used for the center-specific survival analysis as well as new reporting features and query tools to support related quality improvement projects.

Three New Patient Summaries of CIBMTR Research

By Jessica Gillis-Smith, MPH

Three patient summaries of CIBMTR publications have recently been 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.

Join the CIBMTR on Facebook and Twitter

Like us on Facebook and follow us on Twitter to stay up-to-date with important news and events. We promote our publications, share important content from other organizations, and advertise our key meetings and events. Join us today!

 

CIBMTR Advisory Committee

The Advisory Committee, made up of members from across the globe, maintains careful oversight of the CIBMTR research agenda. The committee members are listed on the CIBMTR website, and we sincerely thank all of our committee members for their time and efforts, particularly the following individuals who will complete their service in February.

  • Carmem Bonfim - Vice-Chair (Central / South America)
  • Helen Heslop - Vice-Chair (North America)
  • Ernst Holler - Member at Large (Non-North America)
  • Shinichiro Okamoto - Member at Large (Non-North America)
  • Joseph Pidala - Member at Large (North America)
  • Michael Pulsipher - Member at Large (North America)
  • Miguel Sanz - Member at Large (Non-North America)
  • Bipin Savani - Member at Large (North America)
  • Thomas Shea - Immediate Past Chair
  • Lee Ann Weitekamp - Collection Center Representative

Our Supporters

The CIBMTR is supported by Public Health Service Grant/Cooperative Agreement 5U24-CA076518 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 5U10HL069294 from NHLBI and NCI; a contract HHSH250201200016C with Health Resources and Services Administration (HRSA/DHHS); two Grants N00014-13-1-0039 and N00014-14-1-0028 from the Office of Naval Research; and grants from our corporate and private contributors, which are listed on the CIBMTR website.

 
 
 
 
 
     

    Last Updated: 2/2/2016 2:21 PM
    CIBMTR