Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-25

Study Completion Date

2019-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation

NCT03434730

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Acute Leukemia +6 more

COMPLETED PHASE2

Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide

NCT06828796

Hematologic Disease and Disorders Hematopoietic Cell Transplant

RECRUITING PHASE2

Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation

NCT04395222

Hematologic Malignancy Bone Marrow Transplant

ACTIVE_NOT_RECRUITING PHASE2

PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant

NCT03699631

Hematologic Malignancy

COMPLETED PHASE2

Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT)

NCT01757197

Glucocorticosteroid Refractory Acute GVHD

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cytokine Release Syndrome Stem Cell Transplant Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Adaptive design using two different doses of tocilizumab prophylaxis

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tocilizumab 4 mg/kg

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

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

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

Tocilizumab 8 mg/kg

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

Group Type ACTIVE_COMPARATOR

Tocilizumab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tocilizumab

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Actemra RoActemra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No