Skip to content

Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

Tocilizumab for Cytokine Release Syndrome Prophylaxis in Peripheral Blood Haploidentical Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03533101
Enrollment
30
Registered
2018-05-22
Start date
2018-05-25
Completion date
2019-06-15
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytokine Release Syndrome, Stem Cell Transplant Complications

Keywords

Tocilizumab, Haploidentical, Peripheral blood

Brief summary

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

Detailed description

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.

Interventions

DRUGTocilizumab

IL-6 receptor antibody pre-transplant administration to avoid cytokine release syndrome

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Adaptive design using two different doses of tocilizumab prophylaxis

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Haploidentical transplant recipients * Informed consent signature * Previous diagnosis of any neoplastic, metabolic or autoimmune disease

Exclusion criteria

* History of immune deficiency virus infection * Hepatitis C or B virus infection * Documented bacterial of fungal infection prior to tocilizumab infusion * Previous use of tocilizumab

Design outcomes

Primary

MeasureTime frameDescription
Cytokine release syndrome1 weekIncidence of fever in the first seven days after haploidentical transplantation

Secondary

MeasureTime frameDescription
Hospitalization rate1 weekIncidence of hospitalization in the first seven days after haploidentical transplantation
Adverse effects1 weekAccording to Common Terminology Criteria for Adverse Events v5.0
IL-6 concentration1 weekConcentration of serum IL-6 prior and during the first week after transplantation\|

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026