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OpenTrials
Completed

NCT Number: NCT03533101

Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitario Dr. Jose E Gonzalez UANL

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

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

Other names: Actemra, RoActemra

Primary outcomes

  1. Cytokine release syndrome

    Time frame: 1 week

    Incidence of fever in the first seven days after haploidentical transplantation

Secondary outcomes

  1. Hospitalization rate

    Time frame: 1 week

    Incidence of hospitalization in the first seven days after haploidentical transplantation

  2. Adverse effects

    Time frame: 1 week

    According to Common Terminology Criteria for Adverse Events v5.0

  3. IL-6 concentration

    Time frame: 1 week

    Concentration of serum IL-6 prior and during the first week after transplantation|

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 22, 2018
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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