Unrelated Double Umbilical Cord Blood Units Transplantation

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01015742

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute Leukemia, Lymphoblastic, Acute Leukemia, Myeloid, Chronic	Drug: Stem cell Transplantation	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Stem cell Transplant using two unrelated umbilical cord blood units.	Drug: Stem 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.

Arm

Intervention/Treatment

Experimental: Experimental

Stem cell Transplant using two unrelated umbilical cord blood units.

Drug: Stem 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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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