Unrelated Double Umbilical Cord Blood Units Transplantation

Phase 2

• Conditions: Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute; Leukemia, Myeloid, Chronic
• Interventions: Drug: Stem cell Transplantation

• Registration Number: NCT01015742
• Lead Sponsor: Tehran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04
• Primary Completion: 2012-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Stem cell Transplantation	Stem cell Transplant using two unrelated umbilical cord blood units.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hematology-Oncology & SCT Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of