A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.
NCT ID: NCT04688021
Last Updated: 2023-02-21
Study Results
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.
UNKNOWN
PHASE2
46 participants
INTERVENTIONAL
2020-12-03
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant
NCT03699631
Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)
NCT02208037
Clinical Study of rATG Individualized Administration in Haploidentical Hematopoietic Stem Cell Transplantation
NCT05634915
Abatacept s.c. for aGVHD Prevention in Haplo-HCT
NCT04686929
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
Cytarabine
4 mg/m2/day administered IV day -10 through -9.
Busulfan
3.2 mg/kg/day administered IV day -8 through -6.
Cyclophosphamide
1.8 g/m2/day administered IV day -5 through -4.
Me-CCNU
250mg/m2 once administered orally on day -3.
Rabbit antithymocyte globulin
1.5mg/kg/day administered IV day -5 through -2.
Tocilizumab
8mg/kg administered IV on day -1.
Allogeneic HSCT
Day 0
Cyclosporin A
2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.
Mycophenolate Mofetil
500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
MTX
15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cytarabine
4 mg/m2/day administered IV day -10 through -9.
Busulfan
3.2 mg/kg/day administered IV day -8 through -6.
Cyclophosphamide
1.8 g/m2/day administered IV day -5 through -4.
Me-CCNU
250mg/m2 once administered orally on day -3.
Rabbit antithymocyte globulin
1.5mg/kg/day administered IV day -5 through -2.
Tocilizumab
8mg/kg administered IV on day -1.
Allogeneic HSCT
Day 0
Cyclosporin A
2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.
Mycophenolate Mofetil
500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
MTX
15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient age 16-60 years
* Mother donor, or female donor (age \>50) for female-male transplant
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Creatinine clearance rate \> 60 mL/min (estimate by Cockcroft-Gault Equation)
* alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 2.5×upper limit of normal (ULN), and total bilirubin ≤ 1.5×ULN （upper limit of normal, ULN）
* Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography
* Acceptation to sign the informed consent
Exclusion Criteria
* Present active infection (including bacterial, virus or fungal)
* History of Tocilizumab infection
* History of inflammatory bowel disease
* History of demyelinating disease
* Patients who are HIV-positive, or with uncontrolled chronic hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV) infections
* Women who are pregnant (β-chorionic gonadotropin+) or breast feeding
* Refusal to sign the informed consent
16 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yi Luo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yi Luo
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yi Luo
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TZ-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.