Unrelated Double Umbilical Cord Blood Units Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.

Official Title
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Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies

Conditions
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Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, Leukemia, Myeloid, Chronic

Intervention / Treatment
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* Drug: Stem cell Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hematologically & Histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in Remission Aged 1 year to 50 years Absence of HLA compatible related or other related donor. Availability of suitable UCB units. karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) : 80- 100 Adequate renal function defined as:Serum creatinine <1.5 x normal, Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal Adequate cardiac function defined as: Ejection fraction >50% by echocardiogram. Adequate pulmonary function defined as:Uncorrected DLCO 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air Exclusion Criteria: Age: < 1year or > 50 year Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling or other related donor karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) < 80 HIV positive patients. Female patients who are pregnant or breast feeding Life expectancy severely limited by diseases of vital organs other than the disease indication for transplant Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection Serious psychiatric/ psychological disorders Absence of /inability to provide informed consent Clinical or Paraclinical evidence of CNS or PNS involvement

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Stem cell Transplant using two unrelated umbilical cord blood units. | Drug: Stem cell Transplantation<br>* Busulfan: 3.2 mg/kg IV daily on days -7 to -4 Cyclophosphamide : 60 mg/m² daily on days -3 to -2 Rabbit Thymoglobulin 2.5mg/kg IV daily on days -3 to -2 Cyclosporin will begin on day -2 (IV or oral) for at least 180 days. Target trough level for cyclosporin is 200 ng/ml. In the absence of GVHD, Cyclosporin tapering will begin on day +90 Methyl prednisolone (1mg/kg/d IV) will begin on day -2 to +7 and then 0.5mg/kg until +14 posttransplant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies |  | Until end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil and platelet engraftment |  | 1 year | 
| Severity of acute graft-vs-host disease(GvHD |  | 1 year | 
| Early transplant related mortality |  | 100 days | 
| Overall and disease free survival at one years |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, ALL, CML