A Study to Evaluate the Effect of ATG-F on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical SCT

Study Overview
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Brief Summary
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This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation

Official Title
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An Investigator Initiated, Prospective, Randomized, Controlled Study in Order to Evaluate the Effect of Anti-thymocyte Globulin (Fresenius ATG) on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical Allogeneic Hematopoietic Stem-cell Transplantation

Conditions
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Allogeneic Haplo-Stem Cell Transplatation (SCT), Graft Versus Host Disease

Intervention / Treatment
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* Drug: ATG-F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age 3-70 years old with a disease necessitating allogeneic SCT. Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching). Each patient / patient's guardian must sign written informed consent. Patients must have an ECOG PS ≤ 2; Creatinine <2.0 mg/dl; Ejection fraction >40%; DLCO >50% of predicted; Serum bilirubin <3 gm/dl; elevated GPT or GOT >3 x normal values. Exclusion Criteria: Not fulfilling any of the inclusion criteria. Active life-threatening infection. Overt untreated infection. Known hypersensitivity to ATG. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis. Pregnant or lactating women. Donor contraindication (HIV seropositive confirmed by Western Blot Hepatitis B antigenemia; positive HCV antibodies with positive HCV PCR; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition). Inability to comply with study requirements.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>with ATG-F | Drug: ATG-F<br>* ATG-f<br>|
| No Intervention: 2<br>control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day of day of neutrophil engraftment (ANC>0.5x10^9/L) |  | 30 days | 
| Day of platelet engraftment >25x10^9/L |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AGVHD occurrence |  | 100 days | 
| DFS at 100 days |  | 100 days | 
| Day of platelet engraftment >50x10^9/L |  | 100 days | 
| Time to AGVHD |  | 100 days | 
| AGVHD grade |  | 100 days | 
| OS |  | 100 days | 
| Infections incidence |  | 100 days | 
| TRM |  | 100 days | 
| TRT |  | 100 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mismatched, Stem cell transplatation, Bone marrow transplantation, T cell depletion, engraftment, Patients undergoing allogeneic haplo-SCT