Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

NCT03533101 | Completed Phase 1

• 1 other identifier: HE18-00010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cytokine Release Syndrome; Stem Cell Transplant Complications

Keywords

Tocilizumab; Haploidentical; Peripheral blood

Outcome Measures

Primary Outcomes (1)

• Cytokine release syndrome

  Incidence of fever in the first seven days after haploidentical transplantation

  1 week

Secondary Outcomes (3)

• Hospitalization rate

  1 week

• Adverse effects

  1 week

• IL-6 concentration

  1 week

Study Arms (2)

Tocilizumab 4 mg/kg

EXPERIMENTAL

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

Drug: Tocilizumab

Tocilizumab 8 mg/kg

ACTIVE COMPARATOR

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

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

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

Also known as: Actemra, RoActemra

Tocilizumab 4 mg/kg; Tocilizumab 8 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. Jose E Gonzalez UANL

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (6)

• 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.

  PMID: 27381687 BACKGROUND

• 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.

  PMID: 27543158 BACKGROUND

• 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.

  PMID: 29680516 BACKGROUND

• 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.

  PMID: 27318038 RESULT

• 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.

  PMID: 25456364 RESULT

• 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.

  PMID: 29351985 RESULT

MeSH Terms

Conditions

Cytokine Release Syndrome

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• David Gómez-Almaguer, MD

  Hospital Universitario "Dr. José Eleuterio González"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Adaptive design using two different doses of tocilizumab prophylaxis

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 22, 2018
• Study Start: May 25, 2018
• Primary Completion: May 15, 2019
• Study Completion: June 15, 2019
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

ME (1)