Leukemia, Lymphoblastic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myeloid, Chronic
Conditions
Keywords
AML, ALL, CML
Brief summary
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.
Interventions
DRUGStem cell Transplantation
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.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Iran
Contacts
Primary ContactArdeshir Ghavamzadeh, MD
Outcome results
None listed