The Blood and Marrow Transplant (BMT) program at Ohio State's Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute (OSUCCC – James) has earned international recognition for advancements in treating cancer.
For example, the program developed and demonstrated the effectiveness of a radiation-free preparative regimen for blood and marrow transplantation that is used throughout the world for treating diseases such as chronic myelogenous leukemia. This program was also one of the first to recognize the effectiveness of a donor’s immune system in fighting a patient’s leukemia.
Accredited by all of the major accrediting agencies, the BMT Program offers transplants for a wide variety of diseases using either the patient’s own stem cells or those donated by a family member or an unrelated volunteer. The BMT physicians are all full-time faculty in Ohio State’s College of Medicine, and each has significant subspecialty experience in individual malignancies such as lymphoma, multiple myeloma and leukemia.
As part of Ohio State's Comprehensive Cancer Center, the BMT Program participates in several National Cancer Institute- and Ohio State-sponsored clinical trials. The program has performed more than 2,000 stem cell transplants, a method of replacing immature blood-forming cells that were destroyed by cancer treatment. Given to patients after treatment, stem cells help bone marrow recover so it can continue producing healthy blood cells.
- The BMT Program at the OSUCCC – James conducts novel clinical trials designed to improve outcomes in patients with various blood cancers. The program is particularly focused on patients with acute leukemia, multiple myeloma and non-Hodgkin lymphoma. It treats patients at all stages of disease, but is very interested in enhancing outcomes among those with poor-risk leukemia treated in first remission.
- Diseases treated by experts within the BMT Program include acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), amyloidosis, aplastic anemia, chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), Hodgkin disease, multiple myeloma, myelodysplastic syndrome, myeloproliferative disorders and non-Hodgkin lymphoma (NHL).
The Ohio State Blood and Marrow Transplant Research Consortium
Funded by the National Heart, Lung and Blood Institute of the National Institutes of Health (5U10HL109322-04)
PI: Steven Devine, MD
- Form a consortium of highly experienced transplant centers with a record of productive collaborations to propose, develop and conduct clinical trials within the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).
- Focus on reducing the high risk of relapse observed in patients with recurrent diffuse large B-cell lymphoma (DLCL) following autologous hematopoietic cell transplantation (AHCT). DLCL is the most common type of non-Hodgkin lymphoma.
- Perform a randomized phase II study of high-dose chemotherapy and AHCT followed by maintenance treatment with either lenalidomide or PCI-32765 in patients with DLCL who are at high risk for relapse following AHCT.
- Explore the relationship between molecular subtypes of DLCL.
Clinical Trials for Bone Marrow/Stem Cell Transplantation
(OSU-12213) A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients with Hematological Malignancies
PI: Steven Devine, MD
- Establish the safety and efficacy of subcutaneous plerixafor-mobilized human leukocyte antigen (HLA)-identical sibling allografts in recipients with hematologic malignancies
(OSU-11052) A Phase 1/2a, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous Administration of RGI-2001 in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT)
PI: Yvonne Efebera, MD
- Evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment
- Identify the dose range at which RGI-2001 has an acceptable safety profile and at which biologic activity is observed
- Guide possible dose levels to utilize in later-phase studies based on biological activity
(OSU-12162) A Phase I Study of Milatuzumab (hLL1) for Prevention of Acute Graft-Versus-Host Disease Following Reduced-Intensity Conditioning Allogeneic Stem Cell Transplant in Patients With Hematologic Malignancies
PI: Samantha Jaglowski, MD
Assess the safety and tolerability of milatuzumab (IMMU-115) when added to a standard regimen to prevent graft vs. host disease (GVHD) in patients with hematologic malignancies undergoing stem cell transplant
Recent Clinical Research Accomplishments
Reduced Intensity Regimen Prior to Bone Marrow Transplant is Better for Older Leukemia Patients. A study led by researchers at the OSUCCC – James showed that using a reduced-intensity conditioning regimen to prepare older patients with acute myeloid leukemia (AML) for bone marrow transplants (BMTs) resulted in higher rates of disease-free survival relative to the more typical treatments usually given to these patients. Typically, the prognosis for older patients with AML is poor. Even in patients who achieve complete remission through chemotherapy, survival rates are low due to a high risk of relapse. But with a reduced-intensity regimen leading to a transplant, the disease-free survival rate in older patients reached 39 percent, says Steven Devine, MD, director of the BMT Program at the OSUCCC – James. This study was conducted through the Alliance for Clinical Trials in Oncology and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).
Graft-versus-Host Disease: Why Have We Not Made More Progress? Writing in the journal Current Opinion in Hematology, Samantha Jaglowski, MD and Steven Devine, MD note that, although allogeneic hematopoietic stem cell transplantation (allo-SCT) can cure a number of hematologic malignancies, its use is limited because approximately half of transplant patients develop acute or chronic graft-versus-host disease (GVHD), a potentially fatal complication. But the authors are hopeful that advances over the past decade in grading GVHD, along with the development of biomarkers that provide improved prognostic information, and a growing understanding of the need for prospective studies leading to multicenter studies, can result in better preventive measures for this disease.
Complex Karyotype Predicts for Inferior Outcomes Following Reduced-Intensity Conditioning Allogeneic Transplant for Chronic Lymphocytic Leukemia. A team of OSUCCC – James investigators reported in the British Journal of Haematology their study findings that support further evaluation of complex karyotype (CK) to assess blood and marrow transplant risk for patients with chronic lymphocytic leukemia (CLL). Because CK on metaphase cytogenetics discriminates poor outcome in CLL patients undergoing salvage treatment, this team hypothesized that CK might also provide prognostic information for patients undergoing allogeneic stem cell transplant. Among 51 patients analyzed after transplant, overall survival, event-free survival and cumulative incidence of progression estimates were significantly lower in patients with CK compared with those without CK.
Translational Research Accomplishments
Mini-Molecule Governs Severity of Acute Graft-vs.-Host Disease, Study Finds. Researchers at the OSUCCC – James identified a molecule that helps control the severity of graft-versus-host disease, a life-threatening complication for many leukemia patients who receive a bone marrow transplant. The study used an animal model and tissues from human patients to show that high levels, or overexpression, of a molecule called microRNA-155 (miR-155) controls the severity of acute graft-versus-host disease (GVHD). However, reducing or blocking miR-155 expression decreased acute GVHD severity and increased survival, suggesting a new strategy for treating the condition. Ramiro Garzon, MD, was principal investigator for the study, which was published in the journal Blood.