Acute Graft-versus-host Disease
Conditions
Brief summary
The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.
Detailed description
The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.low dose of IL-2 (40 million U/m2) will be administered from WBC engraftment to day 90 post haploidentical transplantation. IL-2 will be administered three times a week.
Interventions
DRUGInterleukin-2
Interleukin-2 (IL-2), 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days)
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 15-65 years old 2. Acute leukemia in complete remission (CR1/CR2) who received myeloablative haploidentical allo-HSCT 3. WBC engraftment (ANC\>500/ul for continuous 3 days) 4. At least +7d 5. Less than or equal to +15d 6. non T-ALL 7. no active II-IV aGVHD 8. no severe infections 9. Karnofsky score greater than or equal to 90% 10. Haploidentical donor from sibling, children or father 11. Ensure that informed consent signed and faxed to Research Coordinator
Exclusion criteria
1. Exposure to any other clinical trials prior to enrollment 2. Active malignant disease relapses or MRD positive 3. Active, uncontrolled infection 4. Inability to comply with IL-2 treatment regimen 5. Active, uncontrolled II-IV aGVHD 6. Haploidentical donor from mother or collateral donors 7. Clinical Signs of severe pulmonary dysfunction 8. Clinical Signs of sever cardiac dysfunction 9. Receiving corticosteroids as GVHD treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| II-IV acute graft-versus-host disease (aGVHD) post transplantation | Day 100 post transplantation | cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CMV infection post transplantation | Day 100 post transplantation | cumulative incidence of CMV infection post transplantation |
| Measureable residual disease (MRD)-positive test post transplantation | 1 year | cumulative incidence of MRD+ post transplantation |
| Severe chronic GVHD post transplantation | 1 year post transplantation | cumulative incidence of severe chronic GVHD post transplantation |
| Disease-free free survival post transplantation | 1 year | Cumulative incidence of DFS post transplantation |
| Overall survival post transplantation | 1 year | Cumulative incidence of OS post transplantation |
| Hematological relapse post transplantation | 1 year | Cumulative incidence of hematological relapse post transplantation |
Countries
China
Contacts
Primary ContactXiangyu Zhao
Backup ContactXiaosu Zhao
Outcome results
None listed