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2024
Updates and Next Steps for 10-CMS-MDS Study
We are pleased to inform you the Centers for Medicare & Medicaid Services (CMS) released its National Coverage Determination (NCD) for allogeneic hematopoietic cell transplant (HCT) for patients with myelodysplastic syndrome (MDS) on March 6, 2024. The full text of the NCD can be found here.
The effective date of CMS’ new coverage policy is Wednesday, March 6, 2024. Patients receiving allogeneic HCT with Medicare insurance and meeting the above criteria outlined by CMS after this date should receive coverage based on the NCD.
CIBMTR will begin taking steps to close the study and new patients should no longer be asked to sign specific consent for the MDS CED study as of March 6, 2024. Understanding potential lags in reporting to the CIBMTR, tools to enroll patients with MDS who received an alloHCT before March 6, 2024, and not yet reported to CIBMTR will remain available until March 25, 2024.
The studies performed by CIBMTR (10-CMS-MDS) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 1102) generated important evidence supporting CMS’s decision. These studies under CED have provided access to allogeneic HCT for more than 6,000 patients over 65 years with MDS. Much credit should go to the strong advocacy efforts of the American Society of Hematology (ASH) and the American Society for Transplantation and Cellular Therapy (ASTCT) in collaboration with CIBMTR and NMDP over more than 14 years.
Please see further details in CIBMTR’s formal memo HERE.
If you have any questions, please submit a ticket via CIBMTR Center Support.
2023
March 7, 2023 – The National Marrow Donor Program® (NMDP)/Be The Match® in partnership with CIBMTR® (Center for International Blood and Marrow Transplant Research®) and the National Institute of Health’s National Heart, Lung, and Blood Institute (NHLBI) announced that the Journal of the American Medical Association (JAMA) published findings from the Pre-MEASURE study. The research explores a standardized method of assessing measurable residual disease (MRD) before allogeneic hematopoietic stem cell transplantation (HCT) in patients with acute myeloid leukemia (AML). It provides valuable insight into MRD as a predictive tool to inform HCT decisions and individualize treatment to improve outcomes.
2022
Joint Letters Regarding Immunocompromised Patients and COVID-19 Funding
June 21, 2022: The undersigned organizations, all committed to caring for the millions of Americans with impaired immune systems, seek your support to keep this vulnerable population a priority as you consider additional COVID-19 relief funding by prioritizing therapeutic purchasing and research for new therapeutics, such as prophylactic therapies and antiviral medications. Our immunocompromised/suppressed patients are at a higher risk for serious COVID-19 complications and mortality. As COVID-19 continues to evolve, presenting new variants and surges every few months, further federal investment is needed not only to secure an adequate supply of current therapeutics, but to also support the next generation of vaccines and treatments to protect those at highest risk.
Read more:
Letter to the United States Senate
Letter to the U.S. House of Representatives
Signed:
American Academy of Allergy, Asthma & Immunology
American College of Allergy, Asthma & Immunology
American College of Chest Physicians
American College of Rheumatology
American Society of Hematology
American Society of Nephrology
American Society for Transplantation and Cellular Therapy
American Society of Transplantation
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program/Be The Match
April 22, 2022 – 2022 marks the 50th anniversary of the Center for International Blood and Marrow Transplant Research® (CIBMTR®). Cellular therapy has come a long way from its roots in the Cold War of the 1950s, from an experimental treatment for radiation sickness to a standard therapy for leukemia, lymphoma and sickle cell disease. Now, cellular therapy includes both blood and marrow transplantation and other adoptive cellular therapies.
2021
November 30, 2021 – The Center for International Blood and Marrow Transplant Research (CIBMTR) today announced it has been selected as a recipient of the 2021 Amazon Web Services (AWS) Imagine Grant, a public grant opportunity open to registered 501(c) nonprofit organizations in the United States (U.S.) who use technology to solve the world’s most pressing challenges. The grant will support the CIBMTR’s efforts to leverage technology advances to better acquire data and more quickly apply research and learning to accelerate the transformation of patient data into improved patient outcomes.
May 18, 2021 – The CIBMTR® (Center for International Blood and Marrow Transplant Research®) announces the launch of a large observational study, done in collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to understand the safety, efficacy, and durability of responses to COVID-19 vaccines in patients with hematological malignancies and non-malignant blood diseases who have received hematopoietic cell transplantation (HCT) or cellular therapies. The study is supported by National Marrow Donor Program (NMDP)/Be The Match®, The Leukemia & Lymphoma Society (LLS), the National Heart, Lung, and Blood Institute, the National Cancer Institute, the Fred Hutchinson Cancer Research Center, the Multiple Myeloma Research Foundation (MMRF), American Society for Transplantation and Cellular Therapy (ASTCT), and LabCorp.
April 27, 2021 – The CIBMTR® (Center for International Blood & Marrow Transplant Research®) manuscript entitled, "A National Marrow Donor Program Sponsored Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation Using Post-Transplant Cyclophosphamide," has been published in the Journal of Clinical Oncology.
January 19, 2021: People who have had blood or marrow transplant (BMT) may be particularly vulnerable to dying from COVID-19, according to a study published today in the journal, Lancet Haematology, using data reported to the CIBMTR® (Center for International Blood and Marrow Transplant Research), a research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW).
2020
October 31, 2020: The Center for International Blood and Marrow Transplant Research (CIBMTR) launched an upgrade to the DBtC (Data Back to Centers) application—available via the CIBMTR Portal—that includes both more data and new features. DBtC is a part of the suite of applications that provides self-service, on-demand data, and analytics to participating centers. For the first time, enhancements to DBtC enable centers that submit data on chimeric antigen receptor T cells (CAR-T) to the CIBMTR to visualize CAR-T information and HCT information.
October 22, 2020: The CIBMTR® (Center for International Blood and Marrow Transplant Research®), a research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin, is pioneering the automation of transmitting electronic medical record data from its research network partners to its outcomes registry.
September 8, 2020: The CIBMTR® (Center for International Blood and Marrow Transplant Research®) today announced that it has reached a study enrollment goal 2 years early, and 1,500 patients have now enrolled in the post-marketing safety study for Yescarta® (axicabtagene ciloleucel). The study is part of a collaboration with Kite, a Gilead Company.
June 8, 2020: Racism has no place in our society and profession. The American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), the Foundation for the Accreditation of Cellular Therapy (FACT), the International Society for Cell & Gene Therapy (ISCT), and the European Society for Blood and Marrow Transplant (EBMT), all find these acts of racism reprehensible and inexcusable. This cannot be ignored any longer by the global community and our respective organizations.
May 22, 2020: The American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) outlined today their guidelines and measures for combating the spread of COVID-19 while providing protection to transplant patients. The guidelines and measures include new practices for data collection, sharing of information, and administrative relief for facilities impacted by COVID-19 precautions.
February 19, 2020: The CIBMTR® (Center for International Blood and Marrow Transplant Research®) today announced the selection of IQVIA as it seeks to expand the value real-world data can bring to patients, through systematic investigation to generate real-world evidence. IQVIA (NYSE: IQV) is a company known worldwide for its expertise in building technology solutions customized for global research networks engaged in complex data exchange for clinical outcomes registries.
2019
December 9, 2019: Kite, a Gilead Company (Nasdaq: GILD), and the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW), today announced findings from an ongoing post-marketing study evaluating the safety and efficacy of Yescarta® (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma. In this analysis, the efficacy and safety of Yescarta were comparable to that observed in the ZUMA-1 trial, despite a larger proportion of older, more difficult-to-treat patients in the real-world setting. The findings were presented today at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, held in Orlando from December 7–10, 2019.
September 11, 2019: Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, and the CIBMTR® (Center for International Blood and Marrow Transplant Research®) today announced the entry into a research agreement to collect and analyze health outcomes data in patients with hematologic malignancies who receive an allogeneic hematopoietic stem cell transplant (HSCT, or bone marrow transplant) from various donor sources. The CIBMTR is an organization that collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide.
2018
September 14, 2018: A new collaboration focused on tracking long-term outcomes of patients treated with chimeric antigen receptor T-cell (CAR-T) therapies has been established between the CIBMTR® (Center for International Blood and Marrow Transplant Research), and Novartis. Under the terms of the collaboration, CIBMTR will collect long-term safety and efficacy data from patients (pediatrics and adults) treated with Kymriah® (tisagenlecleucel) who agree to participate in the CIBMTR registry for cellular therapy.
May 17, 2018: A new collaboration focused on tracking long-term outcomes of patients treated with chimeric antigen receptor T cell (CAR T) therapies is formed between the CIBMTR® (Center for International Blood and Marrow Transplant Research), and Kite, a Gilead Company. CIBMTR is an organization that collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide. Under the terms of the agreement, CIBMTR will collect and analyze long-term safety and efficacy data for YESCARTA® in a commercial setting.