Hospital Universitario Dr. Jose E Gonzalez UANL
Monterrey, Nuevo León, 64460, Mexico
NCT Number: NCT03533101
Tocilizumab will be administered prior to transplantation in order to prevent the onset of cytokine release syndrome and its complications associated to peripheral blood haploidentical hematopoietic stem cell transplantation with post-transplant cyclophosphamide
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Monterrey, Nuevo León, 64460, Mexico
Cytokine release syndrome (CRS) is a common and potentially severe toxicity associated to haploidentical peripheral blood (PBSC) hematopoietic stem cell transplantation (Haplo-HSCT), which was described previously in the context of immunotherapies for acute lymphoblastic leukemia such as chimeric antigen receptor T-cells and blinatumomab.
CRS is characterized by immune system activation with a high level of circulating inflammatory cytokines including IL-6. Haplo-HSCT recipients have a high incidence of post-transplant fever, with elevated IL-6 in absence of documented infection. CRS occurs more frequently when using PBSC, and severe cases have been associated to delayed engraftment, increased transplant-related mortality and lower survival.
Tocilizumab an IL-6 receptor-targeted monoclonal antibody has been effectively used to treat CRS in several scenarios, including Haplo-HSCT. Therefore, there is considerable interest for the development of a successful strategy for CRS prevention with tocilizumab, potentially eliminating complications. However, it is currently unknown whether the use of this monoclonal antibody can adversely affect the outcome of Haplo-HSCT recipients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IL-6 receptor antibody pre-transplant administration to avoid cytokine release syndrome
Other names: Actemra, RoActemra
Time frame: 1 week
Incidence of fever in the first seven days after haploidentical transplantation
Time frame: 1 week
Incidence of hospitalization in the first seven days after haploidentical transplantation
Time frame: 1 week
According to Common Terminology Criteria for Adverse Events v5.0
Time frame: 1 week
Concentration of serum IL-6 prior and during the first week after transplantation|
Hospital Universitario Dr. Jose E. Gonzalez
Other
Tocilizumab for Cytokine Release Syndrome Prophylaxis in Peripheral Blood Haploidentical Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide
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