At a glance
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A Reduced Intensity Conditioning Regimen With CD3-Depleted Hematopoietic Stem Cells to Improve Survival for Patients With Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating CliniMACS, Stem cell transplantation, and 10 other interventions for Leukemia, Acute Lymphocytic (ALL) and 7 related conditions. Completed, enrolled 73 participants across 1 site.
Detailed Summary
Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor. Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including GVHD and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the body tissues of the patient (the host) are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk for significant infection. For these reasons, a primary focus for researchers is to engineer the graft to provide a T cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to facilitate immune reconstitution and graft integrity. Building on prior institutional trials, this study will provide patients with a haploidentical (HAPLO) graft engineered to specific T cell target values using the CliniMACS system. A reduced intensity, preparative regimen will be used in an effort to reduce regimen-related toxicity and mortality. The primary aim of the study is to help improve overall survival with haploidentical stem cell transplant in this high risk patient population by 1) limiting the complication of graft versus host disease (GVHD), 2) enhancing post-transplant immune reconstitution, and 3) reducing non-relapse mortality.
Study Details
Timeline
Interventions
Miltenyi Biotec CliniMACS stem cell selection device
An infusion of HLA mismatched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
After January 2010, due to the unavailability of muromonab, transplant recipients received a conditioning regimen consisting of systemic chemotherapy and antibodies, including alemtuzumab.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
Transplant recipients will receive a conditioning regimen consisting of systemic chemotherapy and antibodies.
Prior to January 2010, transplant participants received a conditioning regimen consisting of systemic chemotherapy and antibodies, including muromonab. Muromonab became unavailable from the manufacturer at that time and was replaced by alemtuzumab.