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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04688021
Other study ID # TZ-001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 3, 2020
Est. completion date December 31, 2024

Study information

Verified date February 2023
Source First Affiliated Hospital of Zhejiang University
Contact Yi Luo, MD
Phone 86-13666609126
Email luoyijr@zju.edu.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A single-arm trial using Tocilizumab for acute GVHD prophylaxis after haploidentical HSCT.


Description:

This study will enroll haploidentical HSCT patients with high risk for acute GVHD. Tocilizumab (8mg/kg) will be added to the conventional acute GVHD prophylaxis regime (CsA+Methotrexate(MTX)+low dose mycophenolate mofetil(MMF)+ATG) on day -1 of transplant. The previous patients will be used as control.


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date December 31, 2024
Est. primary completion date December 3, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria: - Patients with hematological malignancies in complete remission (CR) who are eligible and planned for haploidentical HSCT. The donor specific antibody is negative - 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: - History of previous HSCT - 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 (ß-chorionic gonadotropin+) or breast feeding - Refusal to sign the informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
Procedure:
Allogeneic HSCT
Day 0
Drug:
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.

Locations

Country Name City State
China The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou

Sponsors (1)

Lead Sponsor Collaborator
Yi Luo

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative incidence of grade II-IV acute graft-versus-host disease Date of symptom onset, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II-IV acute graft-versus-host disease (aGVHD) will be recorded. The aGVHD score of each affected organ will be recorded. 100 days
Primary Cumulative incidence of non grade II-IV acute graft-versus-host disease survival All patients will be tracked from Day 0 to date of grade II-IV acute graft-versus-host disease (aGVHD) onset. Patients who did not present grade II-IV aGVHD or died will be censored at the last date they were assessed and deemed free of grade II-IV aGVHD. 100 days
Secondary Cumulative incidence of engraftment All patients will be tracked from Day 0 to date of myeloid and platelet engraftments, respectively. 100 days
Secondary Cumulative incidence of infections All patients will be tracked from Day 0 to date of infection diagnosis as proved by relevant standard diagnostic criteria. 2 years
Secondary Overall survival (OS) All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
Secondary Progression-free survival (PFS) All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
Secondary Cumulative incidence of transplant-related nonrelapse mortality (NRM) All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
Secondary Cumulative incidence of disease relapse or progression All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. 2 years
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