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Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Completed
CT.gov ID
NCT03533101
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12.7
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Adaptive design using two different doses of tocilizumab prophylaxisAdaptive design using two different doses of tocilizumab prophylaxis
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Tocilizumab for Cytokine Release Syndrome Prophylaxis in Peripheral Blood Haploidentical Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide
Actual Study Start Date :
May 25, 2018
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
Jun 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tocilizumab 4 mg/kg

Tocilizumab 4 mg/kg IV single dose day -1 prior to haploidentical transplantation

Drug: Tocilizumab
IL-6 receptor antibody pre-transplant administration to avoid cytokine release syndrome
Other Names:
  • Actemra
  • RoActemra

    		•
    Active Comparator: Tocilizumab 8 mg/kg

    Tocilizumab 8 mg/kg IV single dose day -1 prior to haploidentical transplantation

    Drug: Tocilizumab
    IL-6 receptor antibody pre-transplant administration to avoid cytokine release syndrome
    Other Names:
  • Actemra
  • RoActemra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cytokine release syndrome [1 week]

      Incidence of fever in the first seven days after haploidentical transplantation

    Secondary Outcome Measures

    1. Hospitalization rate [1 week]

      Incidence of hospitalization in the first seven days after haploidentical transplantation

    2. Adverse effects [1 week]

      According to Common Terminology Criteria for Adverse Events v5.0

    3. IL-6 concentration [1 week]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Dr. Jose E Gonzalez UANL Monterrey Nuevo Leon Mexico 64460

    Sponsors and Collaborators

    • Hospital Universitario Dr. Jose E. Gonzalez

    Investigators

    • Study Director: David Gómez-Almaguer, MD, Hospital Universitario "Dr. José Eleuterio González"

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David Gomez Almaguer, MD, Hospital Universitario Dr. Jose E. Gonzalez
    ClinicalTrials.gov Identifier:
    NCT03533101
    Other Study ID Numbers:
    • HE18-00010
    First Posted:
    May 22, 2018
    Last Update Posted:
    Mar 8, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by David Gomez Almaguer, MD, Hospital Universitario Dr. Jose E. Gonzalez
    Tocilizumab
    Haploidentical
    Peripheral blood
    Additional relevant MeSH terms:
    Syndrome
    Cytokine Release Syndrome

    Study Results

    No Results Posted as of Mar 8, 2021