Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prophylaxis Roles of Low Dose of IL-2 Treatment on GVHD After Haploidentical Transplantation

Conditions
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Acute Graft-versus-host Disease

Intervention / Treatment
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* Drug: Interleukin-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 15-65 years old Acute leukemia in complete remission (CR1/CR2) who received myeloablative haploidentical allo-HSCT WBC engraftment (ANC>500/ul for continuous 3 days) At least +7d Less than or equal to +15d non T-ALL no active II-IV aGVHD no severe infections Karnofsky score greater than or equal to 90% Haploidentical donor from sibling, children or father Ensure that informed consent signed and faxed to Research Coordinator Exclusion Criteria: Exposure to any other clinical trials prior to enrollment Active malignant disease relapses or MRD positive Active, uncontrolled infection Inability to comply with IL-2 treatment regimen Active, uncontrolled II-IV aGVHD Haploidentical donor from mother or collateral donors Clinical Signs of severe pulmonary dysfunction Clinical Signs of sever cardiac dysfunction Receiving corticosteroids as GVHD treatment

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interleukin-2 interventions<br>Patients with standard risk hematologic malignancies undergoing an unmodified haploidentical HCT will be eligible. Once patients achieved neutrophil engraftment will be given 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). | Drug: Interleukin-2<br>* 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)<br>* Other names: IL-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| II-IV acute graft-versus-host disease (aGVHD) post transplantation | cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation | Day 100 post transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe chronic GVHD post transplantation | cumulative incidence of severe chronic GVHD post transplantation | 1 year post transplantation | 
| CMV infection post transplantation | cumulative incidence of CMV infection post transplantation | Day 100 post transplantation | 
| Measureable residual disease (MRD)-positive test post transplantation | cumulative incidence of MRD+ post transplantation | 1 year | 
| Hematological relapse post transplantation | Cumulative incidence of hematological relapse post transplantation | 1 year | 
| Disease-free free survival post transplantation | Cumulative incidence of DFS post transplantation | 1 year | 
| Overall survival post transplantation | Cumulative incidence of OS post transplantation | 1 year |