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Cytokine Release SyndromePhase 1/2NCT03533101

Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

A Phase 1/2 study testing Tocilizumab in people with Cytokine Release Syndrome and Stem Cell Transplant Complications, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMexico
Study dates
25 May 2018to 15 Jun 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Universitario Dr. Jose E Gonzalez UANL

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

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

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

Read the 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.

Being tested
Tocilizumab
Keywords
Tocilizumab, Haploidentical, Peripheral blood
Medical subject headings
Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called Actemra, RoActemra

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

Study groups in NCT03533101
Study groupRoleWhat they receive
Tocilizumab 4 mg/kgExperimentalTocilizumab 4 mg/kg IV single dose day -1 prior to haploidentical transplantation
Receives: Drug: Tocilizumab
Tocilizumab 8 mg/kgActive comparatorTocilizumab 8 mg/kg IV single dose day -1 prior to haploidentical transplantation
Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cytokine release syndrome

    Incidence of fever in the first seven days after haploidentical transplantation

    Measured: 1 week

Secondary outcomes (3)

  1. Hospitalization rate

    Incidence of hospitalization in the first seven days after haploidentical transplantation

    Measured: 1 week

  2. Adverse effects

    According to Common Terminology Criteria for Adverse Events v5.0

    Measured: 1 week

  3. IL-6 concentration

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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start25 May 2018
  3. Primary completion15 May 2019
  4. Study completion15 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Model description
Adaptive design using two different doses of tocilizumab prophylaxis
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533101
Sponsor's protocol ID
HE18-00010
Status last verified
Mar 2021
First submitted
10 May 2018
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tanaka T, Narazaki M, Kishimoto T. Immunotherapeutic implications of IL-6 blockade for cytokine storm. Immunotherapy. 2016 Jul;8(8):959-70. doi: 10.2217/imt-2016-0020.

    PubMed 27381687

  • Teachey DT, Grupp SA. Cytokine Release Syndrome after Haploidentical Stem Cell Transplantation. Biol Blood Marrow Transplant. 2016 Oct;22(10):1736-1737. doi: 10.1016/j.bbmt.2016.08.010. Epub 2016 Aug 16. No abstract available.

    PubMed 27543158

  • Raj RV, Hamadani M, Szabo A, Pasquini MC, Shah NN, Drobyski WR, Shaw BE, Saber W, Rizzo JD, Jerkins J, Fenske TS, D'Souza A, Dhakal B, Zhang C, Konings S, Hari PN, Chhabra S. Peripheral Blood Grafts for T Cell-Replete Haploidentical Transplantation Increase the Incidence and Severity of Cytokine Release Syndrome. Biol Blood Marrow Transplant. 2018 Aug;24(8):1664-1670. doi: 10.1016/j.bbmt.2018.04.010. Epub 2018 Apr 19.

    PubMed 29680516

  • Abboud R, Keller J, Slade M, DiPersio JF, Westervelt P, Rettig MP, Meier S, Fehniger TA, Abboud CN, Uy GL, Vij R, Trinkaus KM, Schroeder MA, Romee R. Severe Cytokine-Release Syndrome after T Cell-Replete Peripheral Blood Haploidentical Donor Transplantation Is Associated with Poor Survival and Anti-IL-6 Therapy Is Safe and Well Tolerated. Biol Blood Marrow Transplant. 2016 Oct;22(10):1851-1860. doi: 10.1016/j.bbmt.2016.06.010. Epub 2016 Jun 16.

    PubMed 27318038

  • Kennedy GA, Varelias A, Vuckovic S, Le Texier L, Gartlan KH, Zhang P, Thomas G, Anderson L, Boyle G, Cloonan N, Leach J, Sturgeon E, Avery J, Olver SD, Lor M, Misra AK, Hutchins C, Morton AJ, Durrant ST, Subramoniapillai E, Butler JP, Curley CI, MacDonald KPA, Tey SK, Hill GR. Addition of interleukin-6 inhibition with tocilizumab to standard graft-versus-host disease prophylaxis after allogeneic stem-cell transplantation: a phase 1/2 trial. Lancet Oncol. 2014 Dec;15(13):1451-1459. doi: 10.1016/S1470-2045(14)71017-4. Epub 2014 Nov 14.

    PubMed 25456364

  • Drobyski WR, Szabo A, Zhu F, Keever-Taylor C, Hebert KM, Dunn R, Yim S, Johnson B, D'Souza A, Eapen M, Fenske TS, Hari P, Hamadani M, Horowitz MM, Rizzo JD, Saber W, Shah N, Shaw B, Pasquini M. Tocilizumab, tacrolimus and methotrexate for the prevention of acute graft-versus-host disease: low incidence of lower gastrointestinal tract disease. Haematologica. 2018 Apr;103(4):717-727. doi: 10.3324/haematol.2017.183434. Epub 2018 Jan 19.

    PubMed 29351985

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tocilizumab in people with Cytokine Release Syndrome and Stem Cell Transplant Complications, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cytokine release syndrome (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533101, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.

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