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.
The study, which has started enrollment, will track 732 patients who have received hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR) T-cell therapy in the last 12 months and receive a COVID-19 vaccination as part of their standard of care. HCT and CAR-T cell therapies are used primarily in patients with blood cancers and other life-threatening blood diseases. The National Comprehensive Cancer Network (NCCN) has recommended that COVID-19 vaccination occur at least three months after cellular therapy but states that COVID-19 vaccine efficacy in the setting of cancer care and a weakened immune system is unknown. However, the current data vacuum about COVID-19 vaccinations in this population results in uncertainty for patients, caregivers, and their medical teams.
Findings from the study will provide physicians with evidence-based guidance and recommendations about COVID-19 vaccinations to their transplant patients.
"It’s critical that we understand the response to these vaccines for immunocompromised patients with serious hematological disorders receiving cellular therapies," says Jeffery J. Auletta, M.D., Senior Vice President, Patient Outcomes & Experience, NMDP and Chief Scientific Director, CIBMTR NMDP. "We also know standard vaccine responses after cellular therapies are diminished, these patients are at increased risk of severe COVID-19 disease and death, so gaining this knowledge is of great importance."
"Given the absence of data about the immunogenicity of any COVID-19 vaccine and no information about the efficacy of mRNA vaccines among this population, it’s imperative to quickly identify correlations of protective vaccine responses from the first wave of vaccinated patients. It’s particularly important to understand the effect of timing of vaccination on immunogenicity because that data will inform future vaccination recommendations and identify patients who might be assessed for the need of revaccination over time. The infrastructure we develop in this process can be readily expanded to study additional SARS-CoV-2 vaccines as they become available," says Mary M. Horowitz, MD, MS, Scientific Director, CIBMTR and Principal Investigator of the BMT CTN Data and Coordinating Center.
"The ability of the CIBMTR and the BMT CTN to leverage their multicenter research infrastructure to address this important question in a timely manner made us enthusiastic to partner with them," said Lee Greenberger, PhD, LLS Chief Scientific Officer. "This effort is an essential piece of LLS’s work to assess the response of all blood cancer patients to COVID-19 vaccines as many patients are immune compromised due to their disease or treatment for their disease."
"People who have received HCT and cellular therapies are eager to know if COVID-19 vaccines will work for them," said Dr. Joshua Hill, who helped develop the study protocol and is an Assistant Professor in the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center. "Our study, which was recommended by the BMT CTN’s State of the Science Committee on Infection and Immune Reconstitution, leverages CIBMTR’s multicenter research network to answer this important question as quickly as possible and will provide clinicians with critical data to inform treatment plans and counsel patients on their immunity against COVID-19 after vaccination, as well as address the optimal timing of vaccination to maximize efficacy."
"The MMRF is committed to answering myeloma patients’ questions, and this effort will rapidly generate much needed data to provide them with answers about the effectiveness of COVID-19 vaccinations," said Daniel Auclair, PhD, Chief Scientific Officer, the MMRF. "By also creating a rich and unique biospecimens resource for analysis, the community will gain a deeper understanding of the immunological consequences of COVID-19 vaccination among blood cancer patients at the B-cell level, and at the T-cell level, as an optimal immune response combines both."
The study uses two existing Institutional Review Board (IRB)-approved protocols managed by the CIBMTR—a research collaboration between NMDP/Be The Match and the Medical College of Wisconsin—for collection of observational data and research specimens. The study is being done in centers that participate in both the CIBMTR and the BMT CTN and makes use of some of BMT CTN’s infrastructure for specimen and supplemental data collection.
The 732 patients enrolled in the study will be in six cohorts defined by type of cellular therapy and timing of vaccination. The primary objective is to compare the immunogenicity of COVID-19 vaccines, in patients starting their vaccination course less than six months after HCT/CAR-T versus those starting the vaccination course six to 12 months after HCT/CAR-T. Patients who meet the protocol’s eligibility criteria and who consent to the collection of four blood samples will be enrolled. The study team estimates this observational study will be completed within a year after it commences.
For information about the study, visit the study website here.
About the CIBMTR
The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW). The CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide to increase survival and enrich quality of life for patients. The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of transplant centers, and a unique and extensive clinical outcomes database. For more information on the CIBMTR, please visit www.cibmtr.org or follow the CIBMTR on Facebook, LinkedIn, or Twitter at @CIBMTR.
About the BMT CTN
The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving cellular therapies. The BMT CTN has completed accrual to 43 Phase II and III trials at more than 100 transplant centers and enrolled over 12,800 study participants. BMT CTN is funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute, both part of the National Institutes of Health (NIH), and is a collaborative effort of 20 Core Transplant Centers/Consortia, the CIBMTR (Center for International Blood and Marrow Transplant Research), the National Marrow Donor Program/Be The Match and the Emmes Company, LLC, a clinical research organization.
About National Marrow Donor Program/Be The Match
The National Marrow Donor Program® (NMDP)/Be The Match® is the leading global partner working to save lives through cellular therapy. With more than 30 years of experience managing the most diverse registry of potential unrelated blood stem cell donors and cord blood units in the world, NMDP/Be The Match is a proven partner in providing cures to patients with life-threatening blood and marrow cancers and diseases. Through their global network, they connect centers and patients to their best cell therapy option—from blood stem cell transplant to a next-generation therapy—and collaborate with cell and gene therapy companies to support therapy development and delivery through Be The Match BioTherapies®. NMDP/Be The Match is a tireless advocate for the cell therapy community, working with hematologists/oncologists to remove barriers to consultation and treatment, and supporting patients through no-cost programs to eliminate non-medical obstacles to cell therapy. In addition, they are a global leader in research through the CIBMTR® (Center for International Blood and Marrow Transplant Research®)—a collaboration with Medical College of Wisconsin, investing in and managing research studies that improve patient outcomes and advance the future of care.
About the Medical College of Wisconsin
With a history dating back to 1893, The Medical College of Wisconsin is dedicated to leadership and excellence in education, patient care, research and community engagement. More than 1,400 students are enrolled in MCW’s medical school and graduate school programs in Milwaukee, Green Bay, and Central Wisconsin. MCW’s School of Pharmacy opened in 2017. A major national research center, MCW is the largest research institution in the Milwaukee metro area and second largest in Wisconsin. In the last ten years, faculty received more than $1.5 billion in external support for research, teaching, training, and related purposes. This total includes highly competitive research and training awards from the National Institutes of Health (NIH). Annually, MCW faculty direct or collaborate on more than 3,100 research studies, including clinical trials. Additionally, more than 1,600 physicians provide care in virtually every specialty of medicine for more than 2.8 million patients annually.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission: cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care. Founded in 1949 and headquartered in Rye Brook, NY, LLS has regional offices throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the LLS Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m., ET. For additional information visit lls.org/lls-newsnetwork. Follow us on Facebook, Twitter, and Instagram.
About the Multiple Myeloma Research Foundation (MMRF)
A pioneer in precision medicine, the Multiple Myeloma Research Foundation (MMRF) seeks to find a cure for all multiple myeloma patients by relentlessly pursuing innovations that accelerate the development of precision treatments for cancer. Founded in 1998 by Kathy Giusti, a multiple myeloma patient, and her twin sister Karen Andrews as a 501(c)(3) nonprofit organization, the MMRF has created the business model around cancer—from data to analytics to the clinic. The MMRF identifies barriers and then finds the solutions to overcome them, bringing in the best partners and aligning incentives in the industry to drive better outcomes for patients. Since its inception, the organization has collected thousands of samples and tissues, opened nearly 100 trials, helped bring 15 FDA-approved therapies to market, and built CoMMpass, the single largest genomic dataset for any cancer. Today, the MMRF is building on its legacy in genomics and is expanding into immunotherapy, as the combination of these two fields will be critical to making precision medicine possible for all patients. The MMRF has raised nearly $500 million and directs nearly 90% of the total funds to research and related programs. To learn more, visit www.themmrf.org.
About the American Society for Transplantation and Cellular Therapy
The American Society for Transplantation and Cellular Therapy (ASTCT), with headquarters in Chicago, is a professional society of 2,600 healthcare professionals and scientists from more than 45 countries who are dedicated to improving the application and success of blood and marrow transplantation and related cellular therapies. ASTCT strives to be the leading organization promoting research, education and clinical practice to deliver the best, comprehensive patient care.
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how Emmes’ research is making a positive impact on human health, visit the Emmes website at www.emmes.com.
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Be The Match/National Marrow Donor Program