Leukemia, Myeloid, Acute Clinical Trial
Official title:
Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 50 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Hematology-Oncology & SCT Research Center | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies | Until end of study | No | |
Secondary | Neutrophil and platelet engraftment | 1 year | Yes | |
Secondary | Severity of acute graft-vs-host disease(GvHD | 1 year | Yes | |
Secondary | Early transplant related mortality | 100 days | Yes | |
Secondary | Overall and disease free survival at one years | 1 year | No |
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