Clinical trial · Interventional
A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.
A Single-arm, Single-center Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.
NCT04688021CI-TRIAL-00064127unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A single-arm trial using Tocilizumab for acute GVHD prophylaxis after haploidentical HSCT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft-versus-host-disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic HSCT | Procedure | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporin A | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Me-CCNU | Drug | — | UNRESOLVED |
| MTX | Drug | Methotrexate | ALIAS |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Rabbit antithymocyte globulin | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tocilizumab cohort
- description
- 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.
- interventionNames
- 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
Primary outcomes (2)
- measure
- Cumulative incidence of grade II-IV acute graft-versus-host disease
- timeFrame
- 100 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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 (β-chorionic gonadotropin+) or breast feeding * Refusal to sign the informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.