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LeukemiaPhase 2NCT04688021

A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.

A Phase 2 study testing Cytarabine, Busulfan and Cyclophosphamide in people with Leukemia and Graft-versus-host-disease, run by Yi Luo at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A single-arm trial using Tocilizumab for acute GVHD prophylaxis after haploidentical HSCT. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Leukemia, Graft-versus-host-disease
What is being tested?
Cytarabine, Busulfan and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
3 Dec 2020to 31 Dec 2024
Phase
Phase 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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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 (β-chorionic gonadotropin+) or breast feeding
  • Refusal to sign the informed consent

Trial locations and contacts

1 site in 1 country.

Yi Luo, MD contact

86-13666609126

luoyijr@zju.edu.com

Lizhen Liu, MD contact

86-15858222740

lizhenliuzju@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou

    Yi Luo, MD, 86-13666609126, luoyijr@zju.edu.com

    Lizhen Liu, MD, 86-15858222740, lizhenliuzju@126.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Single-center Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.

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

Read the detailed 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.

Being tested
Cytarabine, Busulfan, Cyclophosphamide, Me-CCNU, Rabbit antithymocyte globulin
Keywords
hematopoietic stem cell transplantation, graft-versus-host disease
Medical subject headings
Leukemia, Graft vs Host Disease

What participants receive

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

  • CytarabineDrug

    4 mg/m2/day administered IV day -10 through -9.

  • BusulfanDrug

    3.2 mg/kg/day administered IV day -8 through -6.

  • CyclophosphamideDrug

    1.8 g/m2/day administered IV day -5 through -4.

  • Me-CCNUDrug

    250mg/m2 once administered orally on day -3.

  • Rabbit antithymocyte globulinDrug

    1.5mg/kg/day administered IV day -5 through -2.

  • TocilizumabDrug

    8mg/kg administered IV on day -1.

  • Allogeneic HSCTProcedure or surgery

    Day 0

  • Cyclosporin ADrug

    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 MofetilDrug

    500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.

  • MTXDrug

    15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.

Study groups in NCT04688021
Study groupRoleWhat they receive
Tocilizumab cohortExperimentalEach 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.
Receives: Drug: Cytarabine; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Me-CCNU; Drug: Rabbit antithymocyte globulin; Drug: Tocilizumab; Procedure: Allogeneic HSCT; Drug: Cyclosporin A; Drug: Mycophenolate Mofetil; Drug: MTX

What is being measured

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

  1. 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.

    Measured: 100 days

  2. 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.

    Measured: 100 days

Secondary outcomes (6)

  1. Cumulative incidence of engraftment

    All patients will be tracked from Day 0 to date of myeloid and platelet engraftments, respectively.

    Measured: 100 days

  2. Cumulative incidence of infections

    All patients will be tracked from Day 0 to date of infection diagnosis as proved by relevant standard diagnostic criteria.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 2 years

  5. 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.

    Measured: 2 years

  6. 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.

    Measured: 2 years

Timeline

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

  1. First posted29 Dec 2020
  2. Study start3 Dec 2020
  3. Primary completion3 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04688021
Sponsor's protocol ID
TZ-001
Status last verified
Feb 2023
First submitted
11 Dec 2020
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine, Busulfan and Cyclophosphamide in people with Leukemia and Graft-versus-host-disease, run by Yi Luo at 1 site in China.

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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. 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 China. 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 phase mean?

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?

Results are not available in the source record.

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

Contact Yi Luo, MD (86-13666609126, luoyijr@zju.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of grade II-IV acute graft-versus-host disease (time frame: 100 days). The study lists 2 primary outcomes in all. 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 NCT04688021.

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 21 Feb 2023.

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