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A single-arm trial using Tocilizumab for acute GVHD prophylaxis after haploidentical HSCT.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab cohort | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine | Drug | 4 mg/m2/day administered IV day -10 through -9. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of engraftment | All patients will be tracked from Day 0 to date of myeloid and platelet engraftments, respectively. | 100 days |
| Cumulative incidence of infections | All patients will be tracked from Day 0 to date of infection diagnosis as proved by relevant standard diagnostic criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Luo, MD | Contact | 86-13666609126 | luoyijr@zju.edu.com | |
| Lizhen Liu, MD | Contact | 86-15858222740 | lizhenliuzju@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Luo | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | China |
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| Busulfan |
| Drug |
3.2 mg/kg/day administered IV day -8 through -6. |
|
| Cyclophosphamide | Drug | 1.8 g/m2/day administered IV day -5 through -4. |
|
| Me-CCNU | Drug | 250mg/m2 once administered orally on day -3. |
|
| Rabbit antithymocyte globulin | Drug | 1.5mg/kg/day administered IV day -5 through -2. |
|
| Tocilizumab | Drug | 8mg/kg administered IV on day -1. |
|
| Allogeneic HSCT | Procedure | Day 0 |
|
| Cyclosporin A | Drug | 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 | Drug | 500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100. |
|
| MTX | Drug | 15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9. |
|
| 2 years |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D012673 | Semustine |
| C512542 | thymoglobulin |
| C502936 | tocilizumab |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D008130 | Lomustine |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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